Back to resultsStudy to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CY6463
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Cognitive Impairment Associated with Schizophrenia, CIAS, CY6463
Eligibility Criteria
INCLUSION CRITERIA:
- Provides written informed consent to participate in this study
- Body mass index is between 18 to 40 kg/m2
- Fluent English speaker
- Diagnosed with schizophrenia at least 1 year ago
- Psychiatrically stable schizophrenia with no more than moderate symptomatology
- On a stable atypical antipsychotic regimen
- Agrees to use effective contraception throughout the study and for at least 3 months afterward
- Agrees to avoid using tobacco/nicotine and caffeine for several hours at a time
- Agrees to not participate in another study of a drug or device while in this study
EXCLUSION CRITERIA:
- Was in another study of a drug in the past 2 months
- Fails a drug/alcohol screen, including amphetamines, barbiturates, cocaine, marijuana, methadone, methamphetamine, 3,4 methylenedioxymethamphetamine (MDMA), phencyclidine, or nonprescribed benzodiazepines or opiates
- Has had a recent heavy smoking habit (>40 cigarettes/2 packs/day) or recently had nicotine replacement therapy
- Has significant heart disease
- Has hemophilia or any other bleeding/platelet dysfunction condition
- Has hepatitis or HIV
Additional inclusion and exclusion criteria apply, per protocol.
Sites / Locations
- Collaborative Neuroscience Network
- Hassman Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CY6463
Placebo
Arm Description
CY6463 once-daily (QD) for 14 days
placebo QD for 14 days
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
Secondary Outcome Measures
Plasma concentrations of CY6463
Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)
PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)
PK parameter: average concentration during a dosing interval (Cavg)
PK parameter: maximum observed concentration (Cmax)
PK parameter: time to maximum observed concentration (Tmax)
PK parameter: minimum observed concentration (Cmin)
PK parameter: apparent systemic clearance (CL/F)
PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)
PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04972227
Brief Title
Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Official Title
A Double-blinded, Randomized, Placebo-controlled, Multiple-ascending-dose Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tisento Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of CY6463 when administered to participants with stable schizophrenia who are on a stable antipsychotic medication regimen
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Cognitive Impairment Associated with Schizophrenia, CIAS, CY6463
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CY6463
Arm Type
Experimental
Arm Description
CY6463 once-daily (QD) for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo QD for 14 days
Intervention Type
Drug
Intervention Name(s)
CY6463
Intervention Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to study drug discontinuation
Time Frame
28 (±4) days
Secondary Outcome Measure Information:
Title
Plasma concentrations of CY6463
Time Frame
up to Day 15
Title
Pharmacokinetic (PK) parameter: area under the concentration-time curve from time zero (predose) to 24 hours postdose (AUC0-24)
Time Frame
up to Day 15
Title
PK parameter: area under the concentration-time curve during a dosing interval (AUCtau)
Time Frame
up to Day 15
Title
PK parameter: average concentration during a dosing interval (Cavg)
Time Frame
up to Day 15
Title
PK parameter: maximum observed concentration (Cmax)
Time Frame
up to Day 15
Title
PK parameter: time to maximum observed concentration (Tmax)
Time Frame
up to Day 15
Title
PK parameter: minimum observed concentration (Cmin)
Time Frame
up to Day 15
Title
PK parameter: apparent systemic clearance (CL/F)
Time Frame
up to Day 15
Title
PK parameter: accumulation ratio based on a comparison of AUC values after single and multiple dosing (RAUC)
Time Frame
up to Day 15
Title
PK parameter: accumulation ratio based on a comparison of Cmax values after single and multiple dosing (RCmax)
Time Frame
up to Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Provides written informed consent to participate in this study
Body mass index is between 18 to 40 kg/m2
Fluent English speaker
Diagnosed with schizophrenia at least 1 year ago
Psychiatrically stable schizophrenia with no more than moderate symptomatology
On a stable atypical antipsychotic regimen
Agrees to use effective contraception throughout the study and for at least 3 months afterward
Agrees to avoid using tobacco/nicotine and caffeine for several hours at a time
Agrees to not participate in another study of a drug or device while in this study
EXCLUSION CRITERIA:
Was in another study of a drug in the past 2 months
Fails a drug/alcohol screen, including amphetamines, barbiturates, cocaine, marijuana, methadone, methamphetamine, 3,4 methylenedioxymethamphetamine (MDMA), phencyclidine, or nonprescribed benzodiazepines or opiates
Has had a recent heavy smoking habit (>40 cigarettes/2 packs/day) or recently had nicotine replacement therapy
Has significant heart disease
Has hemophilia or any other bleeding/platelet dysfunction condition
Has hepatitis or HIV
Additional inclusion and exclusion criteria apply, per protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Chickering
Organizational Affiliation
Cyclerion Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Assess the Safety and Pharmacokinetics of CY6463 in Participants With Stable Schizophrenia
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