Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301971
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-03-01
Brief Title:
A Study to Assess Mass Balance Pharmacokinetics Metabolism and Excretion of Emraclidine in Healthy Adult Male Participants
Sponsor:
Cerevel Therapeutics LLC
Organization:
Cerevel Therapeutics LLC
Study Overview
Official Title:
A Phase 1 Open-Label Trial to Assess the Mass Balance Pharmacokinetics Metabolism and Excretion of Emraclidine in Healthy Adult Male Participants
Status:
COMPLETED
Status Verified Date:
2024-05
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 study is to determine the mass balance routes and rates of elimination of total radioactivity and characterize the pharmacokinetics PK of emraclidine metabolite CV-0000364 and total radioactivity in plasma and whole blood following a single oral dose of 14C-emraclidine 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