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A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Primary Purpose

Renal Impairment

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Emraclidine
Sponsored by
Cerevel Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: For All Participants Body mass index of ≥18.0 to 42.0 kilograms per meter square (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs]). Sexually active women of childbearing potential must agree to use at least an acceptable birth control method during the trial and for 7 days after the last dose of investigational medicinal product (IMP). Additional Criteria for Participants With Normal Renal Function Age that is within ±10 years of the median age for the renal impairment groups. Body weight that is within ±15% of the median body weight for the renal impairment groups. Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator. Normal renal function: Estimated glomerular filtration rate (eGFR) ≥90 milliliter per minute (mL/min) determined using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value. Additional Criteria for Participants With Renal Impairment Mild, moderate, or severe renal impairment based on eGFR determined using the 2021 CKD-EPI equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value. Stable disease, defined as no clinically significant changes in disease status as documented by most recent eGFR assessment (within at least 3 months before Screening). Stable concomitant medications for the management of individual participant's medical history; on a case-by-case basis, with input from the sponsor, participants receiving fluctuating concomitant medication/treatment may be considered if the underlying disease is under control. Key Exclusion Criteria: For All Participants "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime): Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods [Not Plan] without Intent to Act) Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months): Suicidal Ideation Item 1 (Wish to be Dead) Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Any "yes" response on Suicidal Ideation Item 1 or Item 2 that was within the individual's lifetime but not within the past 12 months should be discussed with the medical monitor prior to inclusion of the participant in the trial. Serious risk of suicide in the opinion of the investigator is also exclusionary. History of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the informed consent form (ICF). Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing. In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of investigational medicinal product (IMP) will be excluded. - Have recently been diagnosed with symptomatic coronavirus disease-2019 (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for SARS-CoV-2 within 15 days prior to signing the ICF. Additional Criteria for Participants With Normal Renal Function - Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for surgically excised non-melanomatous skin cancers or in situ cervical cancer, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial. Additional Criteria for Participants With Renal Impairment Evidence of disease that is not explained by current/known medical history, i.e., organ dysfunction (including malignancies) or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with renal impairment and other underlying conditions. Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list. Participants who require dialysis Participants with nephrotic syndrome. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Tustin, CaliforniaRecruiting
  • Miami, FloridaRecruiting
  • Miami, FloridaRecruiting
  • Orlando, FloridaRecruiting
  • Knoxville, TennesseeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild Renal Impairment

Moderate Renal Impairment

Severe Renal Impairment

Normal Renal Function

Arm Description

Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Participants will receive a single oral dose of 10 mg emraclidine on Day 1.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine

Secondary Outcome Measures

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Number of Participants With Clinically Significant Changes in Vital Signs
Number of Participants With Clinically Significant Change in Laboratory Assessments
Number of Participants With Clinically Significant Change in Physical and Neurological Examination Results
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.

Full Information

First Posted
July 2, 2023
Last Updated
October 11, 2023
Sponsor
Cerevel Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05940402
Brief Title
A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function
Official Title
A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following a Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Renal Impairment Compared With Adult Participants With Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, 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 primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of 10 mg emraclidine on Day 1.
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of 10 mg emraclidine on Day 1.
Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of 10 mg emraclidine on Day 1.
Intervention Type
Drug
Intervention Name(s)
Emraclidine
Other Intervention Name(s)
CVL-231
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time Frame
Pre-dose and at multiple timepoints post-dose up to Day 5
Title
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine
Time Frame
Pre-dose and at multiple timepoints post-dose up to Day 5
Title
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Time Frame
Pre-dose and at multiple timepoints post-dose up to Day 5
Title
Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine
Time Frame
Pre-dose and at multiple timepoints post-dose up to Day 5
Title
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Time Frame
Pre-dose and at multiple timepoints post-dose up to Day 5
Title
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine
Time Frame
Pre-dose and at multiple timepoints post-dose up to Day 5
Secondary Outcome Measure Information:
Title
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to Day 15
Title
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time Frame
Up to Day 5
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame
Up to Day 5
Title
Number of Participants With Clinically Significant Change in Laboratory Assessments
Time Frame
Up to Day 5
Title
Number of Participants With Clinically Significant Change in Physical and Neurological Examination Results
Time Frame
Up to Day 5
Title
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Description
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Time Frame
Up to Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: For All Participants Body mass index of ≥18.0 to 42.0 kilograms per meter square (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs]). Sexually active women of childbearing potential must agree to use at least an acceptable birth control method during the trial and for 7 days after the last dose of investigational medicinal product (IMP). Additional Criteria for Participants With Normal Renal Function Age that is within ±10 years of the median age for the renal impairment groups. Body weight that is within ±15% of the median body weight for the renal impairment groups. Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator. Normal renal function: Estimated glomerular filtration rate (eGFR) ≥90 milliliter per minute (mL/min) determined using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value. Additional Criteria for Participants With Renal Impairment Mild, moderate, or severe renal impairment based on eGFR determined using the 2021 CKD-EPI equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value. Stable disease, defined as no clinically significant changes in disease status as documented by most recent eGFR assessment (within at least 3 months before Screening). Stable concomitant medications for the management of individual participant's medical history; on a case-by-case basis, with input from the sponsor, participants receiving fluctuating concomitant medication/treatment may be considered if the underlying disease is under control. Key Exclusion Criteria: For All Participants "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime): Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods [Not Plan] without Intent to Act) Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months): Suicidal Ideation Item 1 (Wish to be Dead) Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Any "yes" response on Suicidal Ideation Item 1 or Item 2 that was within the individual's lifetime but not within the past 12 months should be discussed with the medical monitor prior to inclusion of the participant in the trial. Serious risk of suicide in the opinion of the investigator is also exclusionary. History of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the informed consent form (ICF). Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing. In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of investigational medicinal product (IMP) will be excluded. - Have recently been diagnosed with symptomatic coronavirus disease-2019 (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for SARS-CoV-2 within 15 days prior to signing the ICF. Additional Criteria for Participants With Normal Renal Function - Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for surgically excised non-melanomatous skin cancers or in situ cervical cancer, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial. Additional Criteria for Participants With Renal Impairment Evidence of disease that is not explained by current/known medical history, i.e., organ dysfunction (including malignancies) or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with renal impairment and other underlying conditions. Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list. Participants who require dialysis Participants with nephrotic syndrome. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Koenig
Organizational Affiliation
Cerevel Therapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Tustin, California
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katia Medina
Phone
714-550-9990
Email
Katia.Medina@ocresearchcenter.com
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Oliva
Phone
305-817-2900
Email
joliva@ErgClinical.com
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dyal Garg
Phone
561-704-4213
Email
dgarg8838@aol.com
Facility Name
Orlando, Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle M. Cortese
Phone
407-988-1075
Email
dcortese@omegarcllc.com
Facility Name
Knoxville, Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzann Cloninger
Phone
865-305-9100
Email
suzann.cloninger@amrllc.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function

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