Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese Cohort - Dose 1 | Experimental |
| |
| Japanese Cohort - Dose 2 | Experimental |
| |
| Japanese Cohort - Dose 3 | Experimental |
| |
| Caucasian Cohort - Dose 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicamtiv | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of Participants with Clinical Laboratory Abnormalities | Day 1 up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Specified dose on specified days |
|
| 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 |