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NCT Number: NCT07629999

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

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

Recruiting

Interested in participating?

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion Coorporate Office Nebraska

Lincoln, Nebraska, 68502, United States

Location status: Recruiting

Location contact

Allen Hunt, Site 0001

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986533

Drug

Specified dose on specified days

Famotidine

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Dabigatran Etexilate

Drug

Specified dose on specified days

Rosuvastatin

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with Adverse Events (AE)

    Time frame: Up to Day 47

  2. Number of participants with Serious Adverse Events (SAE)

    Time frame: Up to Day 47

  3. Number of participants with Vital Sign Abnormalities

    Time frame: Up to Day 27

  4. Number of participants with Physical Examination Abnormalities

    Time frame: Up to Day 27

    Including neurological examination

  5. Number of participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 27

  6. Number of participants with Clinical Laboratory Assessments Abnormalities

    Time frame: 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)

    Time frame: Up to Day 27

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 26 from last dose

  2. Time of maximum observed concentration (Tmax)

    Time frame: 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))

    Time frame: 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))

    Time frame: Up to Day 26 from last dose

    Arm A and Arm C

  5. AUC from Time Zero to 24 Hours (AUC(0-24))

    Time frame: Up to Day 9 from last dose

    Arm A

  6. Elimination Half-Life (T-HALF)

    Time frame: Up to Day 26 from last dose

    Arm A, Arm B, and Arm C

  7. Apparent Total Body Clearance from Plasma (CLT/F)

    Time frame: Up to Day 26 from last dose

    Arm A, Arm B, and Arm C

  8. Apparent Volume of Distribution (Vz/F)

    Time frame: Up to Day 26 from last dose

    Arm A, Arm B, and Arm C

  9. AUC in 1 dosing interval (AUC (TAU))

    Time frame: Up to Day 22 from last dose

    Arm B, D

  10. Cerebrospinal fluid (CSF) concentrations

    Time frame: Up to Day 13

    Arm B

  11. Ratio of total and unbound CSF to plasma concentration

    Time frame: Up to Day 13

    Arm B

  12. Geometric mean ratio of Cmax

    Time frame: Up to Day 26 from last dose

    Arm C, D

  13. Geometric mean ratio of AUC(0-T)

    Time frame: Up to Day 26 from last dose

    Arm C, D

  14. Geometric mean ratio of AUC(INF)

    Time frame: Up to Day 26 from last dose

    Arm C, D

  15. Cmax of dabigatran in plasma

    Time frame: Up to Day 18 from last dose

    Arm D

  16. Cmax of rosuvastatin in plasma

    Time frame: Up to Day 20 from last dose

    Arm D

  17. AUC(0-T) of dabigatran in plasma

    Time frame: Up to Day 18 from last dose

    Arm D

  18. AUC(0-T) of rosuvastatin in plasma

    Time frame: Up to Day 20 from last dose

    Arm D

  19. AUC(INF) of dabigatran in plasma

    Time frame: Up to Day 18 from last dose

    Arm D

  20. AUC(INF) of rosuvastatin in plasma

    Time frame: Up to Day 20 from last dose

    Arm D

  21. Tmax of dabigatran in plasma

    Time frame: Up to Day 18 from last dose

    Arm D

  22. Tmax of rosuvastatin in plasma

    Time frame: Up to Day 20 from last dose

    Arm D

  23. T-HALF of dabigatran in plasma

    Time frame: Up to Day 26 from last dose

  24. T-HALF of rosuvastatin in plasma

    Time frame: Up to Day 20 from last dose

    Arm D

  25. CLT/F of dabigatran in plasma

    Time frame: Up to Day 18 from last dose

    Arm D

  26. CLT/F of rosuvastatin in plasma

    Time frame: Up to Day 27 from last dose

  27. Vz/F of dabigatran in plasma

    Time frame: Up to Day 18 from last dose

    Arm D

  28. Vz/F of rosuvastatin in plasma

    Time frame: Up to Day 20 from last dose

    Arm D

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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