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NCT01517399 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01517399: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01517399 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01517399, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
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.
Primary Outcome
Parameters of S-warfarin/caffeine/midazolam and digoxin (area under the concentration-time curve from time 0 to the last quantifiable concentration \[AUC last\] and area under the curve from time of dosing extrapolated to infinity \[AUC 0-inf\]) when warfarin/caffeine/midazolam and digoxin are administered alone or in combination with tivantinib
Interventions
- DRUG omeprazole
- DRUG caffeine
- DRUG tivantinib
- DRUG s-warfarin
- DIETARY_SUPPLEMENT vitamin K
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01517399 record still lists
NCT01517399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 5 interventions - of which omeprazole is the first listed.
NCT01517399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01517399 about?
NCT01517399 is a clinical study titled "Drug-drug Interaction Study of Tivantinib (ARQ 197) With Omeprazole, S-warfarin, Caffeine, Midazolam, and Digoxin in Cancer Subjects". 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.
What is the current status of trial NCT01517399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01517399?
The interventions under investigation include: omeprazole (DRUG), caffeine (DRUG), tivantinib (DRUG), s-warfarin (DRUG), vitamin K (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01517399?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01517399's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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