Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02994732
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2016-11-14
Brief Title:
Absorption Metabolism and Excretion AME of Single Dose Radiolabeled BVD-523 in Volunteers
Sponsor:
BioMed Valley Discoveries Inc
Organization:
BioMed Valley Discoveries Inc
Study Overview
Official Title:
A Phase 1 Study to Investigate the Absorption Metabolism and Excretion of 14C-BVD-523 Following Single Oral Dose Administration in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2019-03
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 objective of this study is to characterize the metabolic disposition pharmacokinetics PK and routes of elimination of 14C-labeled BVD-523 after administration of a single oral dose to healthy male subjects
The secondary objective of this study is to evaluate the safety and tolerability of a single oral dose of 14C-labeled BVD-523 in healthy male subjects
The secondary objective of this study is to evaluate the safety and tolerability of a single oral dose of 14C-labeled BVD-523 in healthy male subjects
Detailed Description:
This study will be an open-label absorption metabolism and excretion study of 14C-BVD-523 administered as a 600-mg approximately 200 µCi oral dose to 6 healthy male subjects following a 2-hour fast from food not including water that follows breakfast
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None