## Protocol Section
### Identification Module
**NCT ID:** NCT05123079

**Brief Title:** Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants

**Official Title:** A Randomized, 3-Period Crossover Trial to Evaluate the Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Adult Participants

#### Organization Study ID Info
**ID:** CVL-865-1002
#### Organization
**Class:** INDUSTRY
**Full Name:** Cerevel Therapeutics, LLC
### Status Module
#### Completion Date
**Date:** 2021-12-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-01-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-11-21

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-02

**Type:** ACTUAL

**Status Verified Date:** 2022-01

#### Study First Post Date
**Date:** 2021-11-17
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-05
**Study First Submit QC Date:** 2021-11-05
### 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:** This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.

**Detailed Description:** The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Healthy Volunteer

- Bioavailability

- Food effect

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** This is a Phase 1, single-center trial in healthy participants. The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food of Darigabat from a single oral.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oral Dose

**Intervention Names:**

- Drug: Darigabat

**Label:** Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Oral Dose

**Intervention Names:**

- Drug: Darigabat

**Label:** Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food)

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Oral Dose

**Intervention Names:**

- Drug: Darigabat

**Label:** Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food)

- Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food)

- Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food)

**Description:** Tablets

**Name:** Darigabat

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions

**Measure:** Single Dose: Peak Plasma Concentrations

**Time Frame:** Day 1 to Day 4

**Description:** Area under the plasma concentration-time curve (AUC) for Darigabat under fasted conditions

**Measure:** Single Dose: Area under the plasma concentration-time curve

**Time Frame:** Day 1 to Day 4

**Description:** Area under the plasma concentration-time curve from time zero to last concentration measured (AUClast) for Darigabat under fasted conditions

**Measure:** Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured

**Time Frame:** Day 1 to Day 4

**Description:** Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted conditions

**Measure:** Single Dose: Time of Maximum Observed Plasma Concentrations

**Time Frame:** Day 1 to Day 4

**Description:** Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions

**Measure:** Secondary Objective: Single Dose: Peak Plasma Concentrations

**Time Frame:** Day 1 to Day 4

**Description:** Area under the plasma concentration-time curve (AUC) for Darigabat under fed and fasted conditions

**Measure:** Secondary Objective: Single Dose: Area under the plasma concentration-time curve

**Time Frame:** Day 1 to Day 4

**Description:** Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-865 under fed and fasted conditions

**Measure:** Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity

**Time Frame:** Day 1 to Day 4

**Description:** Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted and fed conditions

**Measure:** Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations

**Time Frame:** Day 1 to Day 4

#### Secondary Outcomes

**Description:** Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)

**Measure:** Secondary Outcome (AE)

**Time Frame:** Day 1 to Day 4

**Description:** Number of subjects with clinically significant changes in Electrocardiograms.

**Measure:** Secondary Outcome (ECGs)

**Time Frame:** Day 1 to Day 4

**Description:** Number of subjects with clinically significant changes in laboratory measures.

**Measure:** Secondary Outcome (Labs)

**Time Frame:** Day 1 to Day 4

**Description:** Number of subjects with clinically meaningful changes in vitals signs.

**Measure:** Secondary Outcome (Vital Signs)

**Time Frame:** Day 1 to Day 4

**Description:** Number of subjects with clinically significant changes in physical and neurological exams.

**Measure:** Secondary Outcome (Physical/Neurological Exam)

**Time Frame:** Day 1 to Day 4

**Description:** Changes from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

**Measure:** Secondary Outcome (C-SSRS)

**Time Frame:** Day 1 to Day 4

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Women of nonchildbearing potential and men, ages 18 to 55 years, inclusive.
2. Healthy as determined by medical evaluation by the investigator.
3. Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight \>50 kg (110 lbs).
4. A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception.
5. Capable of giving signed informed consent and complying with study requirements.

Exclusion Criteria:

1. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
2. Serious risk of suicide in the opinion of the investigator.
3. History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
4. Any condition that could possibly affect drug absorption.
5. Receipt of SARS-CoV2 vaccine or booster as follows:

   * mRNA: within 14 days prior to dosing
   * Non-mRNA: within 28 days prior to dosing
6. Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
7. Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
8. History of HIV, hepatitis B, or hepatitis C infection, or positive result for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
9. Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
10. Abnormal clinical laboratory test results or vital measurements at Screening.
11. Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tempe

**Country:** United States

**Facility:** Celerion Inc.

**State:** Arizona

**Zip:** 85283

#### Overall Officials

**Official 1:**

**Affiliation:** Cerevel Therapeutics, LLC

**Name:** Ann M Dandurand, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
