A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

Key facts

Study ID

NCT05806359

Run by

Bristol-Myers Squibb

People needed

33

Starts

2023-03-31

Expected to finish

2023-08-14

Last updated by the study team

2024-05-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.
• Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).
• Caucasian participants must be of European or Latin American Caucasian descent.
• A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.
• Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.

You may not qualify if…

• Any acute or chronic medical illness.
• Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.
• History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• Note: Other protocol-defined inclusion/exclusion criteria apply.

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States

Full record on ClinicalTrials.gov

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