drugset / Trial / NCT01517399

Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects

NCT01517399

Phase 1 Completed 28 enrolled Daiichi Sankyo Medpace, Inc. · collab
SequentialOpen-labelOther

Summary

The purpose of this study is to determine the effects of tivantinib on the pharmacokinetics of omeprazole, s-warfarin, caffein, midazolam, or digoxin in patients with cancer.

Timeline

Start
2011-12
Primary completion
2013-08
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 200 mg Oral
Subject Digoxin Other / unclassified 0.25 mg Oral
Subject Midazolam Small molecule 1.5 mg Intravenous
Subject Omeprazole Other / unclassified 40 mg Oral
Subject S-warfarin Unknown 10 mg Oral
Subject Tivantinib Small molecule 120 mg Oral

Indications