A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests. * Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg. * For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator. Exclusion Criteria: * Participants must not have any significant medical condition or history (renal, hepatic, hem…
Interventions
- DrugBMS-985521
Specified dose on specified days.
- OtherPlacebo
Specified dose on specified days
Location
- CenExel ACT (Formerly Anaheim Clinical Trials; LLC)Anaheim, California