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RecruitingNCT07629999Updated Jul 24, 2026

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

A Phase 1 interventional study of BMS-986533 and Famotidine in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy
  • BMS-986533
  • Food effect
  • pH effect
  • rBA
  • DDI
  • Dabigatran
  • Rosuvastatin
  • Fasted
  • Fed
  • Single ascending dose
  • Multiple ascending dose
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    Arm A

    Drug: BMS-986533 · Drug: Placebo

  • Experimental
    Arm B

    Drug: BMS-986533 · Drug: Placebo

  • Experimental
    Arm C

    Drug: BMS-986533 · Drug: Famotidine

  • Experimental
    Arm D

    Drug: BMS-986533 · Drug: Dabigatran Etexilate · Drug: Rosuvastatin

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

06

What researchers measure

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

    Including neurological examination

    Time frame: Up to Day 27

  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))

    Arm A, Arm B, and Arm C

    Time frame: Up to Day 26 from last dose

  4. AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))

    Arm A and Arm C

    Time frame: Up to Day 26 from last dose

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

    Arm A

    Time frame: Up to Day 9 from last dose

  6. Elimination Half-Life (T-HALF)

    Arm A, Arm B, and Arm C

    Time frame: Up to Day 26 from last dose

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

    Arm A, Arm B, and Arm C

    Time frame: Up to Day 26 from last dose

  8. Apparent Volume of Distribution (Vz/F)

    Arm A, Arm B, and Arm C

    Time frame: Up to Day 26 from last dose

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

    Arm B, D

    Time frame: Up to Day 22 from last dose

  10. Cerebrospinal fluid (CSF) concentrations

    Arm B

    Time frame: Up to Day 13

  11. Ratio of total and unbound CSF to plasma concentration

    Arm B

    Time frame: Up to Day 13

  12. Geometric mean ratio of Cmax

    Arm C, D

    Time frame: Up to Day 26 from last dose

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

    Arm C, D

    Time frame: Up to Day 26 from last dose

  14. Geometric mean ratio of AUC(INF)

    Arm C, D

    Time frame: Up to Day 26 from last dose

  15. Cmax of dabigatran in plasma

    Arm D

    Time frame: Up to Day 18 from last dose

  16. Cmax of rosuvastatin in plasma

    Arm D

    Time frame: Up to Day 20 from last dose

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

    Arm D

    Time frame: Up to Day 18 from last dose

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

    Arm D

    Time frame: Up to Day 20 from last dose

  19. AUC(INF) of dabigatran in plasma

    Arm D

    Time frame: Up to Day 18 from last dose

  20. AUC(INF) of rosuvastatin in plasma

    Arm D

    Time frame: Up to Day 20 from last dose

  21. Tmax of dabigatran in plasma

    Arm D

    Time frame: Up to Day 18 from last dose

  22. Tmax of rosuvastatin in plasma

    Arm D

    Time frame: Up to Day 20 from last dose

  23. T-HALF of dabigatran in plasma

    Time frame: Up to Day 26 from last dose

  24. T-HALF of rosuvastatin in plasma

    Arm D

    Time frame: Up to Day 20 from last dose

  25. CLT/F of dabigatran in plasma

    Arm D

    Time frame: Up to Day 18 from last dose

  26. CLT/F of rosuvastatin in plasma

    Time frame: Up to Day 27 from last dose

  27. Vz/F of dabigatran in plasma

    Arm D

    Time frame: Up to Day 18 from last dose

  28. Vz/F of rosuvastatin in plasma

    Arm D

    Time frame: Up to Day 20 from last dose

07

Study locations

1 of 1 sites recruiting
  • Celerion Coorporate Office Nebraska
    Lincoln, Nebraska 68502, United States
    • Allen Hunt, Site 0001 · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07629999
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 5, 2026
Start date
Jul 13, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jul 24, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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