Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants
- Registration Number
- NCT06577259
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m^2, inclusive.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.
Exclusion Criteria
- Any acute or chronic medical illness.
- History of heart disease.
- Prior exposure to BMS-986435.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A: BMS-986435 Reference Dose 1 BMS-986435 - Treatment B: BMS-986435 Test Dose 1 BMS-986435 - Treatment C: BMS-986435 Test Dose 2 BMS-986435 -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 105 days Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] Up to 105 days Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] Up to 105 days
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)] Up to 105 days Time of maximum observed concentration [Tmax] Up to 105 days Apparent terminal half-life [T-HALF] Up to 105 days Incidence of adverse events (AEs) Up to approximately 5 months Incidence of serious adverse events (SAEs) Up to approximately 5 months Incidence of participants with vital sign abnormalities Up to 105 days Incidence of participants with physical examinations abnormalities Up to 105 days Incidence of participants with electrocardiogram (ECG) abnormalities Up to 105 days Incidence of participants with clinical laboratory abnormalities Up to 105 days
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸San Antonio, Texas, United States