drugset
drugset / Trial / NCT03131973

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

NCT03131973 ↗

Phase 1 Completed 26 enrolled Bristol-Myers Squibb
Non-randomizedSequentialOpen-labelOther

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.

Timeline

Start
2017-05-13
Primary completion
2017-11-05
Completion
2017-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Branebrutinib Small molecule — Oral
Subject Caffeine Small molecule — Oral
Subject Digoxin Other / unclassified — Oral
Subject Flurbiprofen Small molecule — Oral
Subject Methotrexate Small molecule — Oral
Subject Midazolam Small molecule — Oral
Subject Montelukast Other / unclassified — Oral
Subject Omeprazole Other / unclassified — Oral
Subject Pravastatin Small molecule — Oral
Background Leucovorin Small molecule — Oral

Indications

rheumatoid arthritis