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NCT01555866 · ClinicalTrials.gov registry record · Phase 1
Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT01555866: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT01555866 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555866, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.
Primary Outcome
Area under the concentration-time curve from 0 to 72 hours (AUC72) and Maximum concentration (Cmax)
Interventions
- DRUG isavuconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01555866 record still lists
NCT01555866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which isavuconazole is the first listed.
NCT01555866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555866 about?
NCT01555866 is a clinical study titled "Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.". This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.
What is the current status of trial NCT01555866?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-03. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01555866?
The interventions under investigation include: isavuconazole (DRUG).
Who is sponsoring clinical trial NCT01555866?
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 NCT01555866's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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