A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
- Registration Number
- NCT05806359
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Japanese Cohort - Dose 1 Danicamtiv - Japanese Cohort - Dose 1 Placebo - Japanese Cohort - Dose 2 Danicamtiv - Japanese Cohort - Dose 2 Placebo - Japanese Cohort - Dose 3 Danicamtiv - Japanese Cohort - Dose 3 Placebo - Caucasian Cohort - Dose 3 Danicamtiv - Caucasian Cohort - Dose 3 Placebo -
- Primary Outcome Measures
Name Time Method Number of Participants with Clinical Laboratory Abnormalities Day 1 up to Day 7 Number of Participants with Adverse Events (AEs) Day 1 up to Day 28 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
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Predose and at multiple timepoints (Day 1 up to Day 6) after dosing 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
Trial Locations
- Locations (1)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States