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

NCT ID: NCT05123079

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2021-12-07

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

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Oral Dose

Group Type: EXPERIMENTAL

Darigabat

Intervention Type: DRUG

Tablets

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

Oral Dose

Group Type: EXPERIMENTAL

Darigabat

Intervention Type: DRUG

Tablets

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

Oral Dose

Group Type: EXPERIMENTAL

Darigabat

Intervention Type: DRUG

Tablets

Interventions

Darigabat

Tablets

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cerevel Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann M Dandurand, MD

Role: STUDY_DIRECTOR

Cerevel Therapeutics, LLC

Locations

Celerion Inc.

Tempe, Arizona, United States

Countries

United States

Other Identifiers

CVL-865-1002

Identifier Type: -

Identifier Source: org_study_id