Clinical trial NCT05123079: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteer
Bioavailability
Food effect
Lead sponsor: Cerevel Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Single Dose: Peak Plasma Concentrations
timeFrame: Day 1 to Day 4
measure: Single Dose: Area under the plasma concentration-time curve
timeFrame: Day 1 to Day 4
measure: Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured
timeFrame: Day 1 to Day 4
measure: Single Dose: Time of Maximum Observed Plasma Concentrations
timeFrame: Day 1 to Day 4
measure: Secondary Objective: Single Dose: Peak Plasma Concentrations
timeFrame: Day 1 to Day 4
measure: Secondary Objective: Single Dose: Area under the plasma concentration-time curve
timeFrame: Day 1 to Day 4
measure: Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity
timeFrame: Day 1 to Day 4
measure: Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: Secondary Outcome (AE)
timeFrame: Day 1 to Day 4
measure: Secondary Outcome (ECGs)
timeFrame: Day 1 to Day 4
measure: Secondary Outcome (Labs)
timeFrame: Day 1 to Day 4
measure: Secondary Outcome (Vital Signs)
timeFrame: Day 1 to Day 4
measure: Secondary Outcome (Physical/Neurological Exam)
timeFrame: Day 1 to Day 4
measure: Secondary Outcome (C-SSRS)
timeFrame: Day 1 to Day 4
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion Inc.
state: Arizona
Study officials:
affiliation: Cerevel Therapeutics, LLC
name: Ann M Dandurand, MD
role: STUDY_DIRECTOR
References: