NCT05123079

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Darigabat	Tablets

Timeline

• Start date: 2021-11-02
• Primary completion: 2021-11-21
• Completion: 2021-12-07
• First posted: 2021-11-17
• Last updated: 2022-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study