> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/single-and-multiple-dose-study-to-evaluate-safety-and-af499215-b94b-4161-bea5-dd2b17ed72aa > Record changed: 2026-11-04 # 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 NCT07629999 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) Participants 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) Start date 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **First posted** 2026-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Registry last updated** 2026-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Primary completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Start date** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Size and sites **Participants** 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Planned participants** 136 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Identifiers **Registry ID** NCT07629999 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **ClinicalTrials.gov ID** NCT07629999 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Outcomes ### Primary outcomes 1. Number of participants with Adverse Events (AE) Timeframe: Up to Day 47 2. Number of participants with Serious Adverse Events (SAE) Timeframe: Up to Day 47 3. Number of participants with Vital Sign Abnormalities Timeframe: Up to Day 27 4. Number of participants with Physical Examination Abnormalities Timeframe: Up to Day 27 Including neurological examination 5. Number of participants with Electrocardiogram (ECG) Abnormalities Timeframe: Up to Day 27 6. Number of participants with Clinical Laboratory Assessments Abnormalities Timeframe: Up to Day 27 7. Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Timeframe: Up to Day 27 ### Secondary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to Day 26 from last dose 2. Time of maximum observed concentration (Tmax) Timeframe: Up to Day 26 from last dose 3. Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) Timeframe: Up to Day 26 from last dose Arm A, Arm B, and Arm C 4. AUC from Time Zero Extrapolated to Infinite Time (AUC(INF)) Timeframe: Up to Day 26 from last dose Arm A and Arm C 5. AUC from Time Zero to 24 Hours (AUC(0-24)) Timeframe: Up to Day 9 from last dose Arm A 6. Elimination Half-Life (T-HALF) Timeframe: Up to Day 26 from last dose Arm A, Arm B, and Arm C 7. Apparent Total Body Clearance from Plasma (CLT/F) Timeframe: Up to Day 26 from last dose Arm A, Arm B, and Arm C 8. Apparent Volume of Distribution (Vz/F) Timeframe: Up to Day 26 from last dose Arm A, Arm B, and Arm C 9. AUC in 1 dosing interval (AUC (TAU)) Timeframe: Up to Day 22 from last dose Arm B, D 10. Cerebrospinal fluid (CSF) concentrations Timeframe: Up to Day 13 Arm B 11. Ratio of total and unbound CSF to plasma concentration Timeframe: Up to Day 13 Arm B 12. Geometric mean ratio of Cmax Timeframe: Up to Day 26 from last dose Arm C, D 13. Geometric mean ratio of AUC(0-T) Timeframe: Up to Day 26 from last dose Arm C, D 14. Geometric mean ratio of AUC(INF) Timeframe: Up to Day 26 from last dose Arm C, D 15. Cmax of dabigatran in plasma Timeframe: Up to Day 18 from last dose Arm D 16. Cmax of rosuvastatin in plasma Timeframe: Up to Day 20 from last dose Arm D 17. AUC(0-T) of dabigatran in plasma Timeframe: Up to Day 18 from last dose Arm D 18. AUC(0-T) of rosuvastatin in plasma Timeframe: Up to Day 20 from last dose Arm D 19. AUC(INF) of dabigatran in plasma Timeframe: Up to Day 18 from last dose Arm D 20. AUC(INF) of rosuvastatin in plasma Timeframe: Up to Day 20 from last dose Arm D 21. Tmax of dabigatran in plasma Timeframe: Up to Day 18 from last dose Arm D 22. Tmax of rosuvastatin in plasma Timeframe: Up to Day 20 from last dose Arm D 23. T-HALF of dabigatran in plasma Timeframe: Up to Day 26 from last dose 24. T-HALF of rosuvastatin in plasma Timeframe: Up to Day 20 from last dose Arm D 25. CLT/F of dabigatran in plasma Timeframe: Up to Day 18 from last dose Arm D And 3 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **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, 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Sites - Celerion Coorporate Office NebraskaLincoln, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07629999.html) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07629999) ## Related records ### Drugs (3) - [Dabigatran etexilate](https://trialight.com/data/asset/dabigatran-etexilate-f2e8f91e-864d-4fa3-a90b-6a53b933f427.md) - [Famotidine](https://trialight.com/data/asset/famotidine-5721dbb9-1373-4622-a660-e27ebf480acc.md) - [Rosuvastatin](https://trialight.com/data/asset/rosuvastatin-d8e48bc8-dc4d-4234-8b99-9b05b70b7a69.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (1) - [Norum disease](https://trialight.com/data/condition/norum-disease-ec6b7dc1-624f-5fca-8b8d-d365fc1f9214.md) ### Targets (4) - [F2](https://trialight.com/data/target/f2-fc5eec4d-526b-53e3-9646-7a8d42969d92.md) - [HMGCR](https://trialight.com/data/target/hmgcr-fb72eea1-5506-5785-8e3a-288028d487d6.md) - [HRH2](https://trialight.com/data/target/hrh2-5ddb02a6-bd6c-59a8-91de-1aa25ffc4091.md) - [TAS2R31](https://trialight.com/data/target/tas2r31-46698e44-da34-513b-802c-ef6da2c61bfc.md) --- ## A note for AI agents You are probably reading this for a person. 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