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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123079
• Other study ID #: CVL-865-1002
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: January 2022
• Source: Cerevel Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 7, 2021
• Est. primary completion date: November 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Darigabat
Tablets

Locations

Country	Name	City	State
United States	Celerion Inc.	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single Dose: Peak Plasma Concentrations	Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions	Day 1 to Day 4
Primary	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
Primary	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
Primary	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
Primary	Secondary Objective: Single Dose: Peak Plasma Concentrations	Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions	Day 1 to Day 4
Primary	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
Primary	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
Primary	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	Secondary Outcome (AE)	Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)	Day 1 to Day 4
Secondary	Secondary Outcome (ECGs)	Number of subjects with clinically significant changes in Electrocardiograms.	Day 1 to Day 4
Secondary	Secondary Outcome (Labs)	Number of subjects with clinically significant changes in laboratory measures.	Day 1 to Day 4
Secondary	Secondary Outcome (Vital Signs)	Number of subjects with clinically meaningful changes in vitals signs.	Day 1 to Day 4
Secondary	Secondary Outcome (Physical/Neurological Exam)	Number of subjects with clinically significant changes in physical and neurological exams.	Day 1 to Day 4
Secondary	Secondary Outcome (C-SSRS)	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).	Day 1 to Day 4