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

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2013

Conditions
Solid Tumors
Interventions
DRUG

tivantinib

three oral 120 mg tablets administered twice a day

DRUG

omeprazole

One 40 mg oral capsule once alone and once again with tivantinib

DRUG

s-warfarin

One 10 mg oral tablet once alone and once again with tivantinib

DRUG

caffeine

One 200 mg oral tablet once alone and once again with tivantinib

DIETARY_SUPPLEMENT

vitamin K

One oral 5 mg tablet on multiple days when and around warfarin administration

DRUG

digoxin

One oral 0.25 mg tablet once alone and once again with tivantinib

DRUG

midazolam

Intravenous 1.5 mg dose once alone and once again with tivantinib

Trial Locations (1)

78229

START - South Texas Accelerated Research Therapeutics, LLC, San Antonio

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY