Healthy Volunteers
Conditions
Keywords
Healthy, BMS-986533, Food effect, pH effect, rBA, DDI, Dabigatran, Rosuvastatin, Fasted, Fed, Single ascending dose, Multiple ascending dose
Brief 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
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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AE) | Up to Day 47 | — |
| Number of participants with Serious Adverse Events (SAE) | Up to Day 47 | — |
| Number of participants with Vital Sign Abnormalities | Up to Day 27 | — |
| Number of participants with Physical Examination Abnormalities | Up to Day 27 | Including neurological examination |
| Number of participants with Electrocardiogram (ECG) Abnormalities | Up to Day 27 | — |
| Number of participants with Clinical Laboratory Assessments Abnormalities | 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) | Up to Day 27 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 26 from last dose | — |
| Time of maximum observed concentration (Tmax) | 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)) | Up to Day 26 from last dose | Arm A, Arm B, and Arm C |
| AUC from Time Zero Extrapolated to Infinite Time (AUC(INF)) | Up to Day 26 from last dose | Arm A and Arm C |
| AUC from Time Zero to 24 Hours (AUC(0-24)) | Up to Day 9 from last dose | Arm A |
| Elimination Half-Life (T-HALF) | Up to Day 26 from last dose | Arm A, Arm B, and Arm C |
| Apparent Total Body Clearance from Plasma (CLT/F) | Up to Day 26 from last dose | Arm A, Arm B, and Arm C |
| Apparent Volume of Distribution (Vz/F) | Up to Day 26 from last dose | Arm A, Arm B, and Arm C |
| AUC in 1 dosing interval (AUC (TAU)) | Up to Day 22 from last dose | Arm B, D |
| Cerebrospinal fluid (CSF) concentrations | Up to Day 13 | Arm B |
| Ratio of total and unbound CSF to plasma concentration | Up to Day 13 | Arm B |
| Geometric mean ratio of Cmax | Up to Day 26 from last dose | Arm C, D |
| Geometric mean ratio of AUC(0-T) | Up to Day 26 from last dose | Arm C, D |
| Geometric mean ratio of AUC(INF) | Up to Day 26 from last dose | Arm C, D |
| Cmax of dabigatran in plasma | Up to Day 18 from last dose | Arm D |
| Cmax of rosuvastatin in plasma | Up to Day 20 from last dose | Arm D |
| AUC(0-T) of dabigatran in plasma | Up to Day 18 from last dose | Arm D |
| AUC(0-T) of rosuvastatin in plasma | Up to Day 20 from last dose | Arm D |
| AUC(INF) of dabigatran in plasma | Up to Day 18 from last dose | Arm D |
| AUC(INF) of rosuvastatin in plasma | Up to Day 20 from last dose | Arm D |
| Tmax of dabigatran in plasma | Up to Day 18 from last dose | Arm D |
| Tmax of rosuvastatin in plasma | Up to Day 20 from last dose | Arm D |
| T-HALF of dabigatran in plasma | Up to Day 26 from last dose | — |
| T-HALF of rosuvastatin in plasma | Up to Day 20 from last dose | Arm D |
| CLT/F of dabigatran in plasma | Up to Day 18 from last dose | Arm D |
| CLT/F of rosuvastatin in plasma | Up to Day 27 from last dose | — |
| Vz/F of dabigatran in plasma | Up to Day 18 from last dose | Arm D |
| Vz/F of rosuvastatin in plasma | Up to Day 20 from last dose | Arm D |
Countries
United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed