A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg. * Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status. * A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF. Exclusion Criteria: * Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic…
Interventions
- DrugBMS-986533
Specified dose on specified days
- DrugFamotidine
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
- DrugDabigatran Etexilate
Specified dose on specified days
- DrugRosuvastatin
Specified dose on specified days
Location
- Local Institution - 0001Lincoln, Nebraska