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NCT01813461 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
A Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01813461: Completed Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole, sponsored by Astellas Pharma Global Development.
NCT01813461 is a Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 8 participants, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01813461, a Phase 1 study of Healthy Subjects and Pharmacokinetics of 14C-labeled Isavuconazole, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
Conditions Studied
Interventions
- DRUG 14C-labeled prodrug isavuconazonium sulfate
Study Locations (1)
Wisconsin
- Covance - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-10 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01813461 record still lists
NCT01813461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 129-participant average among 69 other Healthy Subjects trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which 14C-labeled prodrug isavuconazonium sulfate is the first listed.
NCT01813461 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01813461 about?
NCT01813461 is a clinical study titled "Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects". The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
What is the current status of trial NCT01813461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-10. Estimated completion is 2012-11.
What conditions does trial NCT01813461 study?
This clinical trial studies the following conditions: Healthy Subjects, Pharmacokinetics of 14C-labeled Isavuconazole.
What interventions are being tested in trial NCT01813461?
The interventions under investigation include: 14C-labeled prodrug isavuconazonium sulfate (DRUG).
Who is sponsoring clinical trial NCT01813461?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01813461 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Subjects
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01813461's enrollment target sits among peer trials
8 66th of 69 higher than 4 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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.
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