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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Danicamtiv

Study type: Interventional

Funder types: Industry

Identifiers

NCT05806359

CV028-1001

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 4 patient groups

Japanese Cohort - Dose 1

Experimental group

Treatment:

Drug: Danicamtiv

Drug: Placebo

Japanese Cohort - Dose 2

Experimental group

Treatment:

Drug: Danicamtiv

Drug: Placebo

Japanese Cohort - Dose 3

Experimental group

Treatment:

Drug: Danicamtiv

Drug: Placebo

Caucasian Cohort - Dose 3

Experimental group

Treatment:

Drug: Danicamtiv

Drug: Placebo