Healthy Volunteers
Conditions
Keywords
Healthy, Danicamtiv, Japanese, Caucasian
Brief summary
The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.
Interventions
DRUGDanicamtiv
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Clinical Laboratory Abnormalities | Day 1 up to Day 7 |
| Number of Participants with Vital Sign Abnormalities | Day 1 up to Day 7 |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Day 1 up to Day 7 |
| Number of Participants with Physical Examination Abnormalities | Day 1 up to Day 7 |
| Number of Participants with Adverse Events (AEs) | Day 1 up to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Time of Maximum Observed Plasma Concentration (Tmax) | Predose and at multiple timepoints (Day 1 up to Day 6) after dosing |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] | Predose and at multiple timepoints (Day 1 up to Day 6) after dosing |
| Maximum Observed Plasma Concentration (Cmax) | Predose and at multiple timepoints (Day 1 up to Day 6) after dosing |
Countries
United States
Outcome results
None listed