Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435923
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2024-05-24
Brief Title:
A Trial to Assess the Absorption Metabolism Excretion and Mass Balance of 14C-Darigabat After a Single Oral Dose in Healthy Male Participants
Sponsor:
Cerevel Therapeutics LLC
Organization:
Cerevel Therapeutics LLC
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None