Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-01 @ 1:52 AM
Study NCT ID:
NCT05719805
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Establish Bioequivalence of 1 × 15-mg Mavacamten Capsule to 3 × 5-mg Mavacamten Capsules in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2023-10
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 purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: