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

NCT01517399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-02-12

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Hamim Zahir, BPharm, PhD · Daiichi Sankyo UK Ltd.

Study Design

Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01517399 on ClinicalTrials.gov