BMS-986533 safety and PK in healthy adults with food, pH, and drug interactions
Official title: 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
Run by Bristol-Myers Squibb · NCT07629999 · Data updated 2026-11-12
This study tests how safe BMS-986533 is and how it behaves in the body in healthy adults, and looks at how food, stomach pH, and other medicines might affect its absorption.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 136 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Lincoln, Nebraska) |
| Status | Recruiting |
| Started | July 13, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | July 24, 2026 |
| Trial ID | NCT07629999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults with BMI 18–32.44 kg/m2, weight ≥50 kg, and no significant health issues.
✕Probably not a fit
The study may not benefit those with underlying health problems or those who experience adverse effects or intolerances to the study drug or co-administered medications.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional trial in healthy volunteers evaluating single and multiple doses of BMS-986533. The study also examines how food and stomach pH influence relative bioavailability and whether common drugs affect its pharmacokinetics via P-gp and BCRP transporters. It includes comparisons with placebo and additional agents to assess drug-drug interaction potential. Participants will be monitored for safety and PK parameters across different dosing and co-medication conditions.
Why it matters
Potential benefit: If successful, participants may contribute to determining proper dosing and safety of BMS-986533 for future studies in patients.
How similar studies have gone: Early-phase studies of similar compounds have shown the feasibility of assessing safety and PK with food, pH, and transporter-mediated interactions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication). * Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease. * Participants must not have any major surgery within 3 months of study intervention administration. * Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery). * Other protocol defined inclusion/exclusion criteria applies.
Where it's running
-
Celerion Coorporate Office Nebraska
Lincoln, Nebraska, United States Recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.