Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03131973

Run by

Bristol-Myers Squibb

People needed

26

Starts

2017-05-13

Expected to finish

2017-11-10

Last updated by the study team

2017-12-15

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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