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
- 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
- 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
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-06-01
- First posted
- 2026-06-05
- Registry last updated
- 2026-07-24
- Primary completion date
- 2027-06-01
- Start date
- 2026-07-13
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Bristol-Myers Squibb
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07629999
- ClinicalTrials.gov ID
- NCT07629999
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Number of participants with Adverse Events (AE)
Timeframe: Up to Day 47
Number of participants with Serious Adverse Events (SAE)
Timeframe: Up to Day 47
Number of participants with Vital Sign Abnormalities
Timeframe: Up to Day 27
Number of participants with Physical Examination Abnormalities
Timeframe: Up to Day 27
Including neurological examination
Number of participants with Electrocardiogram (ECG) Abnormalities
Timeframe: Up to Day 27
Number of participants with Clinical Laboratory Assessments Abnormalities
Timeframe: Up to Day 27
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
Maximum observed concentration (Cmax)
Timeframe: Up to Day 26 from last dose
Time of maximum observed concentration (Tmax)
Timeframe: Up to Day 26 from last dose
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
AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))
Timeframe: Up to Day 26 from last dose
Arm A and Arm C
AUC from Time Zero to 24 Hours (AUC(0-24))
Timeframe: Up to Day 9 from last dose
Arm A
Elimination Half-Life (T-HALF)
Timeframe: Up to Day 26 from last dose
Arm A, Arm B, and Arm C
Apparent Total Body Clearance from Plasma (CLT/F)
Timeframe: Up to Day 26 from last dose
Arm A, Arm B, and Arm C
Apparent Volume of Distribution (Vz/F)
Timeframe: Up to Day 26 from last dose
Arm A, Arm B, and Arm C
AUC in 1 dosing interval (AUC (TAU))
Timeframe: Up to Day 22 from last dose
Arm B, D
Cerebrospinal fluid (CSF) concentrations
Timeframe: Up to Day 13
Arm B
Ratio of total and unbound CSF to plasma concentration
Timeframe: Up to Day 13
Arm B
Geometric mean ratio of Cmax
Timeframe: Up to Day 26 from last dose
Arm C, D
Geometric mean ratio of AUC(0-T)
Timeframe: Up to Day 26 from last dose
Arm C, D
Geometric mean ratio of AUC(INF)
Timeframe: Up to Day 26 from last dose
Arm C, D
Cmax of dabigatran in plasma
Timeframe: Up to Day 18 from last dose
Arm D
Cmax of rosuvastatin in plasma
Timeframe: Up to Day 20 from last dose
Arm D
AUC(0-T) of dabigatran in plasma
Timeframe: Up to Day 18 from last dose
Arm D
AUC(0-T) of rosuvastatin in plasma
Timeframe: Up to Day 20 from last dose
Arm D
AUC(INF) of dabigatran in plasma
Timeframe: Up to Day 18 from last dose
Arm D
AUC(INF) of rosuvastatin in plasma
Timeframe: Up to Day 20 from last dose
Arm D
Tmax of dabigatran in plasma
Timeframe: Up to Day 18 from last dose
Arm D
Tmax of rosuvastatin in plasma
Timeframe: Up to Day 20 from last dose
Arm D
T-HALF of dabigatran in plasma
Timeframe: Up to Day 26 from last dose
T-HALF of rosuvastatin in plasma
Timeframe: Up to Day 20 from last dose
Arm D
CLT/F of dabigatran in plasma
Timeframe: Up to Day 18 from last dose
Arm D
And 3 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Celerion Coorporate Office NebraskaLincoln, United StatesRecruiting
- Related resource (www.bms.com)
- Related resource (www.bmsclinicaltrials.com)