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NCT01657825 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01657825: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT01657825 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657825, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of warfarin after single dose administration.
Primary Outcome
Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf), AUC from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
Interventions
- DRUG Warfarin
- DRUG Isavuconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01657825 record still lists
NCT01657825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT01657825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01657825 about?
NCT01657825 is a clinical study titled "Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects". The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of warfarin after single dose administration.
What is the current status of trial NCT01657825?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-06. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01657825?
The interventions under investigation include: Warfarin (DRUG), Isavuconazole (DRUG).
Who is sponsoring clinical trial NCT01657825?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01657825's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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