Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants
Recruiting
Phase 1Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
136 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Eligibility 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) …
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.
Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
First line of the email MUST contain NCT # and Site #.
CONTACT
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