NCT06435923

A Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat After a Single Oral Dose in Healthy Male Participants

A Phase 1, Open-Label Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat Following a Single Oral Dose in Healthy Adult Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of \[14C\]-darigabat in healthy adult male participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	[14C]-darigabat	Oral capsule

Timeline

• Start date: 2024-05-29
• Primary completion: 2024-07-02
• Completion: 2024-07-03
• First posted: 2024-05-30
• Last updated: 2024-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study