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

• Status: Completed
• Trial end date: 2017-11-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Branebrutinib; Caffeine; Digoxin; Flurbiprofen; Leucovorin; Methotrexate; Midazolam; Montelukast; Omeprazole; Pravastatin

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