search
Back to results

A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MK-5720
Placebo to MK-5720
MK-8189
Placebo to MK-8189
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia Can discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (which ever in longer) prior to the start of the treatment period and during the study Exclusion Criteria: The main exclusion criteria include but are not limited to the following: Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator Has history of mental retardation, borderline personality disorder, or organic brain syndrome Has a history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia Has a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures Has a family history of sudden death Has claustrophobia to a degree that prevents tolerance of magnetic resonance imaging (MRI) scanning procedure Has a metallic implant of any sort that prevents MRI examination, or any other contraindication to MRI examination Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV) Has received or is currently receiving treatment with clozapine for any length of time Has received any live vaccines within 30 days prior to the first dose of study intervention or is scheduled to receive any live vaccine through 60 days following study intervention

Sites / Locations

  • California Clinical Trials Medical Group managed by PAREXEL ( Site 0003)Recruiting
  • Velocity Clinical Research, Hallandale Beach ( Site 0002)Recruiting
  • Research Centers of America ( Hollywood ) ( Site 0001)Recruiting
  • Hassman Research Institute Marlton Site ( Site 0007)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Panel A

Panel B

Panel C

Panel D

Panel E

Panel F

Arm Description

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 at a specified Dose 1 or a dose matched placebo (Period 2).

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 2 or a dose matched placebo (Period 2).

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 3 or a dose matched placebo (Period 2).

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 4 or a dose matched placebo (Period 2).

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 5 or a dose matched placebo (Period 2).

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 6 or a dose matched placebo (Period 2).

Outcomes

Primary Outcome Measures

Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
Number of Participants Who Experience ≥1 AE(s) in Period 2
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
Number of Participants Who Discontinue Study Due to an AE in Period 1
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study due to an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE in Period 2
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study due to an AE will be reported.
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK 5720
Blood samples will be collected at specified intervals for the determination of AUC0-last. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of MK-5720.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC-inf) of MK-5720
Blood samples will be collected at specified intervals for the determination of AUC-inf. AUC0-inf is defined as the area under concentration-time curve of MK-5720 from time zero to infinity.
Maximum Serum Concentration (Cmax) of MK-5720
Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-5720 reached.
Time to Maximum Concentration (Tmax) of MK-5720
Blood samples will be collected at specified intervals for the determination of Tmax. Tmax is defined as the time to maximum concentration of MK-5720 reached.
Apparent Clearance (CL/F) of MK-5720
Blood samples will be collected at specified intervals for the determination of CL/F. CL/F is the rate at which the MK-5720 is completely removed from plasma.
Apparent Volume of Distribution (Vz/F) of MK-5720
Blood samples will be collected at specified intervals for the determination of Vz/F. Vz/F is the apparent volume of distribution of MK-5720.
Apparent Terminal Half-life (t1/2) of MK-5720
Blood samples will be collected at specified intervals for the determination t1/2. t1/2 is defined as the time required to divide plasma concentration of MK-5720 by half after reaching pseudo-equilibrium.
Area Under the concentration-Time Curve from Time 0 to 28 Days (AUC0-28d) of MK-8189
Blood samples will be collected at specified intervals for the determination of AUC0-28d. AUC0-28d is defined as the area under the concentration-time curve from time zero to 28 days of MK-8189 (a metabolite of MK-5720).
AUC0-inf of MK-8189
Blood samples will be collected at specified intervals for the determination of AUC-inf. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity of MK-8189 (a metabolite of MK-5720).
Cmax of MK-8189
Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-8189 (a metabolite of MK-5720) reached.
Tmax of MK-8189
Blood samples will be collected at specified intervals for the determination of Tmax. Tmax is defined as the time to maximum concentration of MK-8189 (a metabolite of MK-5720).
Concentration at Day 28 (C28d) of MK-8189
Blood samples will be collected at specified intervals for the determination of C28d. C28d is defined as the maximum concentration from time zero to 28 days of MK-8189 (a metabolite of MK-5720).
CL/F of MK-8189
Blood samples will be collected at specified intervals for the determination of CL/F. CL/F is the rate at which the MK-8189 (a metabolite of MK-5720) is completely removed from plasma.
Vz/F of MK-8189
Blood samples will be collected at specified intervals for the determination of Vz/F. Vz/F is the apparent volume of distribution of MK-8189 (a metabolite of MK-5720).
t1/2 of MK-8189
Blood samples will be collected at specified intervals for the determination of Half-life (t1/2). t1/2 is defined as the time required to divide plasma concentration of MK-8189 (a metabolite of MK-5720) by half after reaching pseudo-equilibrium.

Secondary Outcome Measures

C28d Tied to Specific Exposures of MK-8189
Blood samples will be collected at specified intervals for the determination of C28d tied to specific exposures of MK-8189 (metabolite of MK-5720). C28d tied to specific exposures of MK-8189 is defined as the maximum concentration from time zero to 28 days of MK-8189 tied to specific exposures.
AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of AUC0-28 of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-28 is defined as the area under the plasma concentration-time curve from time zero to 28 days of MK-8189.
AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of AUC-inf of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity of MK-8189.
Cmax of MK-8189 in Gluteal Muscle Versus Cmax of MK-8189 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of Cmax of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. Cmax is defined as the maximum concentration of MK-8189.
Tmax of MK-8189 in Gluteal Muscle Versus Tmax of MK-8189 in Deltoid Muslce
Blood samples will be collected at specified intervals for determination of Tmax of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. Tmax is defined as the time to maximum concentration of MK-8189 (metabolite of MK-5720).
C28d of MK-8189 in Gluteal Muscle Versus C28d in Deltoid Muslce
Blood samples will be collected at specified intervals for the determination of C28d of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. C28d is defined as the maximum concentration from time zero to 28 days of MK-8189.
CL/F of MK-8189 in Gluteal Muscle Versus CL/F in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of CL/F of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. CL/F is the rate at which the MK-8189 is completely removed from plasma.
Vz/F of MK-8189 in Gluteal Muscle Versus Vz/F of MK-8189 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of distribution of MK-8189 (metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle versus deltoid muscle. Vz/F is the apparent volume of distribution of MK-8189.
t1/2 of MK-8189 in Gluteal Muscle Versus t1/2 of MK-8189 in Deltoid Muslce
Blood samples will be collected at specified intervals for the determination of t1/2 of MK-8189 (metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. t1/2 is defined as the time required divide plasma concentration of MK-8189 (metabolite of MK-5720) by half after reaching pseudo-equilibrium.
AUC0-last of MK 5720 in Gluteal Muscle Versus AUC0-last of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of AUC0-last after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of MK-5720.
AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of AUC-inf after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity.
Cmax of MK-5720 in Gluteal Muscle Versus Cmax of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of Cmax after administration of MK-5720 in the gluteal muscle and deltoid muscle. Cmax is defined as the maximum concentration of MK-5720 reached.
Tmax of MK-5720 in Gluteal Muscle Versus Tmax of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of Tmax after administration of MK-5720 in the gluteal muscle and deltoid muscle. Tmax is defined as the time to maximum concentration of MK-5720 reached.
CL/F of MK-5720 in Gluteal Muscle Versus CL/F of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination of CL/F after administration of MK-5720 in the gluteal muscle and deltoid muscle. CL/F is the rate at which the MK-5720 is completely removed from plasma.
Vz/F of MK-5720 in Gluteal Muscle Versus Vz/F of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination Vz/F after administration of MK-5720 in the gluteal muscle and deltoid muscle. Vz/F is the apparent volume of distribution of MK-5720.
t1/2 of MK-5720 in Gluteal Muscle Versus t1/2 of MK-5720 in Deltoid Muscle
Blood samples will be collected at specified intervals for the determination t1/2 after administration of MK-5720 in the gluteal muscle and deltoid muscle. t1/2 is defined as the time required to divide plasma concentration of MK-5720 by half after reaching pseudo-equilibrium.

Full Information

First Posted
July 12, 2023
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05953740
Brief Title
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
Official Title
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Long-Acting Injectable of MK-5720 in Participants With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
September 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending intramuscular doses of MK-5720, and the safety and tolerability of multiple once-daily oral doses of MK-8189, in participants with schizophrenia. The primary study hypothesis is that the administration of MK-5720 is safe and well tolerated.
Detailed Description
In Period 1, participants receive once-daily MK-8189 for 7 days, followed by a 72-hour washout. In Period 2, participants receive a single dose of MK-5720.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Panel A
Arm Type
Experimental
Arm Description
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 at a specified Dose 1 or a dose matched placebo (Period 2).
Arm Title
Panel B
Arm Type
Experimental
Arm Description
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 2 or a dose matched placebo (Period 2).
Arm Title
Panel C
Arm Type
Experimental
Arm Description
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 3 or a dose matched placebo (Period 2).
Arm Title
Panel D
Arm Type
Experimental
Arm Description
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 4 or a dose matched placebo (Period 2).
Arm Title
Panel E
Arm Type
Experimental
Arm Description
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 5 or a dose matched placebo (Period 2).
Arm Title
Panel F
Arm Type
Experimental
Arm Description
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 6 or a dose matched placebo (Period 2).
Intervention Type
Drug
Intervention Name(s)
MK-5720
Intervention Description
MK-5720 IM injection
Intervention Type
Drug
Intervention Name(s)
Placebo to MK-5720
Other Intervention Name(s)
Normal saline, Dextrose
Intervention Description
Placebo matched to MK-5720 IM injection
Intervention Type
Drug
Intervention Name(s)
MK-8189
Intervention Description
MK-8189 tablet taken by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo to MK-8189
Intervention Description
Placebo tablet matched to MK-8189
Primary Outcome Measure Information:
Title
Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1
Description
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
Time Frame
Up to approximately 12 Months
Title
Number of Participants Who Experience ≥1 AE(s) in Period 2
Description
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
Time Frame
Up to approximately 12 Months
Title
Number of Participants Who Discontinue Study Due to an AE in Period 1
Description
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study due to an AE will be reported.
Time Frame
Up to approximately 12 Months
Title
Number of Participants Who Discontinue Study Due to an AE in Period 2
Description
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study due to an AE will be reported.
Time Frame
Up to approximately 12 Months
Title
Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK 5720
Description
Blood samples will be collected at specified intervals for the determination of AUC0-last. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of MK-5720.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC-inf) of MK-5720
Description
Blood samples will be collected at specified intervals for the determination of AUC-inf. AUC0-inf is defined as the area under concentration-time curve of MK-5720 from time zero to infinity.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Maximum Serum Concentration (Cmax) of MK-5720
Description
Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-5720 reached.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Time to Maximum Concentration (Tmax) of MK-5720
Description
Blood samples will be collected at specified intervals for the determination of Tmax. Tmax is defined as the time to maximum concentration of MK-5720 reached.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Apparent Clearance (CL/F) of MK-5720
Description
Blood samples will be collected at specified intervals for the determination of CL/F. CL/F is the rate at which the MK-5720 is completely removed from plasma.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Apparent Volume of Distribution (Vz/F) of MK-5720
Description
Blood samples will be collected at specified intervals for the determination of Vz/F. Vz/F is the apparent volume of distribution of MK-5720.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Apparent Terminal Half-life (t1/2) of MK-5720
Description
Blood samples will be collected at specified intervals for the determination t1/2. t1/2 is defined as the time required to divide plasma concentration of MK-5720 by half after reaching pseudo-equilibrium.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Area Under the concentration-Time Curve from Time 0 to 28 Days (AUC0-28d) of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of AUC0-28d. AUC0-28d is defined as the area under the concentration-time curve from time zero to 28 days of MK-8189 (a metabolite of MK-5720).
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdose
Title
AUC0-inf of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of AUC-inf. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity of MK-8189 (a metabolite of MK-5720).
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Cmax of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-8189 (a metabolite of MK-5720) reached.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Tmax of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of Tmax. Tmax is defined as the time to maximum concentration of MK-8189 (a metabolite of MK-5720).
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Concentration at Day 28 (C28d) of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of C28d. C28d is defined as the maximum concentration from time zero to 28 days of MK-8189 (a metabolite of MK-5720).
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdose
Title
CL/F of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of CL/F. CL/F is the rate at which the MK-8189 (a metabolite of MK-5720) is completely removed from plasma.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Vz/F of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of Vz/F. Vz/F is the apparent volume of distribution of MK-8189 (a metabolite of MK-5720).
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
t1/2 of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of Half-life (t1/2). t1/2 is defined as the time required to divide plasma concentration of MK-8189 (a metabolite of MK-5720) by half after reaching pseudo-equilibrium.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Secondary Outcome Measure Information:
Title
C28d Tied to Specific Exposures of MK-8189
Description
Blood samples will be collected at specified intervals for the determination of C28d tied to specific exposures of MK-8189 (metabolite of MK-5720). C28d tied to specific exposures of MK-8189 is defined as the maximum concentration from time zero to 28 days of MK-8189 tied to specific exposures.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 postdose
Title
AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of AUC0-28 of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-28 is defined as the area under the plasma concentration-time curve from time zero to 28 days of MK-8189.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdose
Title
AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of AUC-inf of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity of MK-8189.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Cmax of MK-8189 in Gluteal Muscle Versus Cmax of MK-8189 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of Cmax of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. Cmax is defined as the maximum concentration of MK-8189.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Tmax of MK-8189 in Gluteal Muscle Versus Tmax of MK-8189 in Deltoid Muslce
Description
Blood samples will be collected at specified intervals for determination of Tmax of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. Tmax is defined as the time to maximum concentration of MK-8189 (metabolite of MK-5720).
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, 1320 hours postdose
Title
C28d of MK-8189 in Gluteal Muscle Versus C28d in Deltoid Muslce
Description
Blood samples will be collected at specified intervals for the determination of C28d of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. C28d is defined as the maximum concentration from time zero to 28 days of MK-8189.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 432, 456, 504, and 672 hours postdose
Title
CL/F of MK-8189 in Gluteal Muscle Versus CL/F in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of CL/F of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. CL/F is the rate at which the MK-8189 is completely removed from plasma.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Vz/F of MK-8189 in Gluteal Muscle Versus Vz/F of MK-8189 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of distribution of MK-8189 (metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle versus deltoid muscle. Vz/F is the apparent volume of distribution of MK-8189.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
t1/2 of MK-8189 in Gluteal Muscle Versus t1/2 of MK-8189 in Deltoid Muslce
Description
Blood samples will be collected at specified intervals for the determination of t1/2 of MK-8189 (metabolite of MK-5720) after administration of MK-5720 in the gluteal muscle and deltoid muscle. t1/2 is defined as the time required divide plasma concentration of MK-8189 (metabolite of MK-5720) by half after reaching pseudo-equilibrium.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
AUC0-last of MK 5720 in Gluteal Muscle Versus AUC0-last of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of AUC0-last after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of MK-5720.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of AUC-inf after administration of MK-5720 in the gluteal muscle and deltoid muscle. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Cmax of MK-5720 in Gluteal Muscle Versus Cmax of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of Cmax after administration of MK-5720 in the gluteal muscle and deltoid muscle. Cmax is defined as the maximum concentration of MK-5720 reached.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Tmax of MK-5720 in Gluteal Muscle Versus Tmax of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of Tmax after administration of MK-5720 in the gluteal muscle and deltoid muscle. Tmax is defined as the time to maximum concentration of MK-5720 reached.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
CL/F of MK-5720 in Gluteal Muscle Versus CL/F of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination of CL/F after administration of MK-5720 in the gluteal muscle and deltoid muscle. CL/F is the rate at which the MK-5720 is completely removed from plasma.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
Vz/F of MK-5720 in Gluteal Muscle Versus Vz/F of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination Vz/F after administration of MK-5720 in the gluteal muscle and deltoid muscle. Vz/F is the apparent volume of distribution of MK-5720.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose
Title
t1/2 of MK-5720 in Gluteal Muscle Versus t1/2 of MK-5720 in Deltoid Muscle
Description
Blood samples will be collected at specified intervals for the determination t1/2 after administration of MK-5720 in the gluteal muscle and deltoid muscle. t1/2 is defined as the time required to divide plasma concentration of MK-5720 by half after reaching pseudo-equilibrium.
Time Frame
Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia Can discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (which ever in longer) prior to the start of the treatment period and during the study Exclusion Criteria: The main exclusion criteria include but are not limited to the following: Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator Has history of mental retardation, borderline personality disorder, or organic brain syndrome Has a history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia Has a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures Has a family history of sudden death Has claustrophobia to a degree that prevents tolerance of magnetic resonance imaging (MRI) scanning procedure Has a metallic implant of any sort that prevents MRI examination, or any other contraindication to MRI examination Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV) Has received or is currently receiving treatment with clozapine for any length of time Has received any live vaccines within 30 days prior to the first dose of study intervention or is scheduled to receive any live vaccine through 60 days following study intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
California Clinical Trials Medical Group managed by PAREXEL ( Site 0003)
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-403-2515
Facility Name
Velocity Clinical Research, Hallandale Beach ( Site 0002)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-455-5757
Facility Name
Research Centers of America ( Hollywood ) ( Site 0001)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-604-3900
Facility Name
Hassman Research Institute Marlton Site ( Site 0007)
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
267-981-8911

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
http://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information

Learn more about this trial

A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)

We'll reach out to this number within 24 hrs