A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
- Registration Number
- NCT06027437
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive
- Participants with resting heart rate ≥ 55 bpm
- Seasonal allergies that do not require medication at the time of the study are acceptable
Exclusion Criteria
- Any acute or chronic medical illness
- Head injury, intracranial tumor, or aneurysm within 2 years prior to screening
- History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment B Danicamtiv - Treatment C Danicamtiv - Treatment A Danicamtiv -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to day 16 Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF)) Up to day 16 Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) Up to day 16
- Secondary Outcome Measures
Name Time Method Number of participants with Electrocardiogram (ECG) abnormalities Up to day 16 Time of maximum observed plasma concentration (Tmax) Up to day 16 Terminal elimination half-life (T-HALF) Up to day 16 Apparent total body clearance (CLT/F) Up to day 16 Apparent volume of distribution (Vz/F) Up to day 16 Number of participants with Adverse Events (AEs) Up to day 43 Number of participants with Serious Adverse Events (SAEs) Up to day 43 Number of participants with vital sign abnormalities Up to day 16 Number of participants with Physical Examination (PE) abnormalities Up to day 16 Number of participants with clinical laboratory abnormalities Up to day 16
Trial Locations
- Locations (1)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States