Rheumatoid Arthritis
Conditions
Brief summary
Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
Interventions
DRUGBMS-986195
Specified dose on specified days
DRUGMethotrexate
Specified dose on specified days
DRUGLeucovorin
Specified dose on specified days
DRUGCaffeine
Specified dose on specified days
DRUGMontelukast
Specified dose on specified days
DRUGFlurbiprofen
Specified dose on specified days
DRUGOmeprazole
Specified dose on specified days
DRUGMidazolam
Specified dose on specified days
DRUGDigoxin
Specified dose on specified days
DRUGPravastatin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female (not of childbearing potential) participants as determined by medical and surgical history and assessments * Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive * Normal kidney function at screening
Exclusion criteria
* History of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months * History of headaches related to caffeine withdrawal, including energy drinks * History of syncope, orthostatic instability, or recurrent dizziness Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 26 days | Measured by plasma concentrations |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Up to 26 days | Measured by plasma concentrations |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to 26 days | Measured by plasma concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinical laboratory test abnormalities | Up to 28 days | — |
| Number of participants with vital sign measurement abnormalities | Up to 28 days | — |
| Number of participants with adverse events | Up to 28 days | Measured by investigator assessment |
| Number of participants with physical examination abnormalities | Up to 28 days | — |
| Number of participants with marked abnormalities in clinical laboratory test results | Up to 28 days | — |
| Number of participants with electrocardiogram abnormalities | Up to 28 days | — |
| Number of participants with serious adverse events | Up to 45 days | Measured by investigator assessment |
| Number of participants with adverse events leading to discontinuation | Up to 28 days | Measured by investigator assessment |
Countries
United States
Outcome results
None listed