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NCT01535547 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study of Isavuconazole and Tacrolimus
A Phase 1 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01535547: Completed Phase 1 study, sponsored by Astellas Pharma.
NCT01535547 is a Phase 1 study that has completed, run by Astellas Pharma. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01535547, a Phase 1 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 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 tacrolimus after single dose administration.
Primary Outcome
Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), AUC from time 0 extrapolated to infinity (AUCinf), and maximum concentration (Cmax), time to attain Cmax (tmax) , apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F) and apparent terminal elimination half-life (t1/2 ).
Interventions
- DRUG tacrolimus
- DRUG isavuconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01535547 record still lists
NCT01535547 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which tacrolimus is the first listed.
NCT01535547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01535547 about?
NCT01535547 is a clinical study titled "Drug Interaction Study of Isavuconazole and Tacrolimus". The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of tacrolimus after single dose administration.
What is the current status of trial NCT01535547?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-12. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01535547?
The interventions under investigation include: tacrolimus (DRUG), isavuconazole (DRUG).
Who is sponsoring clinical trial NCT01535547?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01535547's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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