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

NCT05123079 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-865-1002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Volunteer; Bioavailability; Food effect

Outcome Measures

Primary Outcomes (8)

• Single Dose: Peak Plasma Concentrations

  Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions

  Day 1 to Day 4

• Single Dose: Area under the plasma concentration-time curve

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

  Day 1 to Day 4

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

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

  Day 1 to Day 4

• Single Dose: Time of Maximum Observed Plasma Concentrations

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

  Day 1 to Day 4

• Secondary Objective: Single Dose: Peak Plasma Concentrations

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

  Day 1 to Day 4

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

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

  Day 1 to Day 4

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

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

  Day 1 to Day 4

• Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations

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

  Day 1 to Day 4

Secondary Outcomes (6)

• Secondary Outcome (AE)

  Day 1 to Day 4

• Secondary Outcome (ECGs)

  Day 1 to Day 4

• Secondary Outcome (Labs)

  Day 1 to Day 4

• Secondary Outcome (Vital Signs)

  Day 1 to Day 4

• Secondary Outcome (Physical/Neurological Exam)

  Day 1 to Day 4

Study Arms (3)

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

EXPERIMENTAL

Oral Dose

Drug: Darigabat

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

EXPERIMENTAL

Oral Dose

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

Oral Dose

Drug: Darigabat

Interventions

Darigabat DRUG

Tablets

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)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Serious risk of suicide in the opinion of the investigator.
• History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
• Any condition that could possibly affect drug absorption.
• Receipt of SARS-CoV2 vaccine or booster as follows:
• mRNA: within 14 days prior to dosing
• Non-mRNA: within 28 days prior to dosing
• Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
• Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
• 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.
• Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
• Abnormal clinical laboratory test results or vital measurements at Screening.
• 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.

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (1)

Celerion Inc.

Tempe, Arizona, 85283, United States

Location

Study Officials

• Ann M Dandurand, MD

  Cerevel Therapeutics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 2, 2021
• Primary Completion: November 21, 2021
• Study Completion: December 7, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

US (1)