Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT02994732
Status:
COMPLETED
Last Update Posted:
2019-06-17
First Post:
2016-11-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers
Sponsor:
BioMed Valley Discoveries, Inc
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: