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

Cerevel Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Darigabat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05123079

CVL-865-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

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

Experimental group

Description:

Oral Dose

Treatment:

Drug: Darigabat

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

Experimental group

Description:

Oral Dose

Treatment:

Drug: Darigabat

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

Experimental group

Description:

Oral Dose

Treatment:

Drug: Darigabat