## Protocol Section
### Identification Module
**NCT ID:** NCT06435923

**Brief Title:** A Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat After a Single Oral Dose in Healthy Male Participants

**Official Title:** A Phase 1, Open-Label Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat Following a Single Oral Dose in Healthy Adult Male Participants

#### Organization Study ID Info
**ID:** CVL-865-HV-1004
#### Organization
**Class:** INDUSTRY
**Full Name:** Cerevel Therapeutics, LLC
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cerevel Therapeutics, LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of \[14C\]-darigabat in healthy adult male participants.

### Conditions Module

**Conditions:**

- Healthy Participants

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive a single oral dose of darigabat.

**Intervention Names:**

- Drug: [14C]-darigabat

**Label:** Darigabat

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Darigabat

**Description:** Oral capsule

**Name:** [14C]-darigabat

**Other Names:**

- CVL-865; PF-06372865

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Area Under the Concentration Time Curve (AUC) from Time Zero to Infinity (AUCinf) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** AUC from Time 0 to the Time of the Last Measured Concentration (AUClast) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Maximum Observed Plasma Concentration (Cmax) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Time to Last Quantifiable (Tlast) Concentration of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Time to Maximum Observed Concentration (Tmax) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Terminal Phase Half-life (t½) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Apparent Total Clearance After Oral Administration (CL/F) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Darigabat

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Ratio of Plasma AUCinf for Darigabat to Total Radioactivity

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma Total Radioactivity

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Description:** Urine PK parameters will be assessed.

**Measure:** Amount Excreted in Urine (Aeu) of Total Radioactivity

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Description:** Fecal PK parameters will be assessed.

**Measure:** Amount Excreted in Feces (Aef) of Total Radioactivity

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

#### Secondary Outcomes

**Measure:** Metabolite Profile of [14C]-darigabat in Plasma, Urine and Feces

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Identification of [14C]-darigabat Metabolites Found in Plasma, Urine and Feces

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Structural Elucidation of [14C]-darigabat Metabolites ≥10% of the Total [14C]-darigabat Radioactivity Found in Plasma, Urine and Feces

**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15

**Measure:** Number of Participants with Adverse Events (AEs)

**Time Frame:** Up to Day 16

**Measure:** Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values

**Time Frame:** Up to Day 15

**Measure:** Number of Participants with Clinically Significant Changes in Vital Signs

**Time Frame:** Up to Day 15

**Measure:** Number of Participants with Clinically Significant Changes in Laboratory Assessments

**Time Frame:** Up to Day 15

**Measure:** Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results

**Time Frame:** Up to Day 15

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Body mass index of 18.5 to 35.0 kilograms per square meters (kg/m\^2), inclusive, and a total body weight ≥50 kg \[110 Pounds (lbs)\] at Screening.
2. A male participant who is sexually active with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during the trial and for 93 days after the dose of investigational medicinal product (IMP). In addition, male participants should not donate sperm for a minimum of 93 days following the dose of IMP.
3. Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.

Exclusion Criteria:

1. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, 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.
2. "Yes" responses for any of the following items on the Columbia-Suicide Severity Rating Scale (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) Serious risk of suicide in the opinion of the investigator is also exclusionary.
3. Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
4. Positive result for human immunodeficiency viruses (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral Ribonucleic acid (RNA) levels at Screening. Note: Positive or indeterminate test result for hepatitis C antibody should follow with hepatitis C virus polymerase chain reaction (PCR) RNA test. If result is positive, the participant is excluded.
5. Positive drug screen \[including cotinine and Tetrahydrocannabinol (THC)\] or a positive test for alcohol.
6. Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

**Gender Based:** True

**Gender Description:** U.S. Food and Drug Administration (FDA) recommends that radiation exposure to participants should be kept as low as is reasonably achievable, and there is no available data to suggest metabolism of the darigabat is different in women versus men. Hence, female participants are excluded from this study.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cerevelclinicaltrials@cerevel.com

**Name:** Cerevel Clinical Trial Support

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Austin

**Country:** United States

**Facility:** Austin, Texas

**State:** Texas

**Zip:** 78744

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000018757

- Term: GABA Modulators

- ID: D000018682

- Term: GABA Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M269476

- Name: PF-06372865

- Relevance: HIGH

- As Found: Mosunetuzumab

- ID: M20827

- Name: GABA Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000630159

- Term: PF-06372865

### Misc Info Module

- Version Holder: 2024-05-31
