Clinical trial NCT03131973: Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
Official title: Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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 exclusion criteria could apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 26 days
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 26 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 26 days
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 28 days
measure: Number of participants with serious adverse events
timeFrame: Up to 45 days
measure: Number of participants with adverse events leading to discontinuation
timeFrame: Up to 28 days
measure: Number of participants with clinical laboratory test abnormalities
timeFrame: Up to 28 days
measure: Number of participants with vital sign measurement abnormalities
timeFrame: Up to 28 days
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to 28 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 28 days
measure: Number of participants with marked abnormalities in clinical laboratory test results
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: