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NCT01651325 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects
A Phase 1 study of Pharmacokinetics of Isavuconazole and Healthy Adult Volunteers, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01651325: Completed Phase 1 study of Pharmacokinetics of Isavuconazole and Healthy Adult Volunteers, sponsored by Astellas Pharma Global Development.
NCT01651325 is a Phase 1 study of Pharmacokinetics of Isavuconazole and Healthy Adult Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 24 participants, below the 58-participant average among 4 other Pharmacokinetics of Isavuconazole trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01651325, a Phase 1 study of Pharmacokinetics of Isavuconazole and Healthy Adult Volunteers, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.
Primary Outcome
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity (AUCinf), maximum concentration (Cmax), and AUC from time of dosing to the last quantifiable concentration (AUClast).
Conditions Studied
Interventions
- DRUG Isavuconazole
- DRUG dextromethorphan
Study Locations (1)
Maryland
- Parexel - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01651325 record still lists
NCT01651325 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 58-participant average among 4 other Pharmacokinetics of Isavuconazole trials with a reported enrollment target (59% lower).
The record links to 3 conditions, with Pharmacokinetics of Isavuconazole appearing as the primary indexed condition, and to 2 interventions - of which Isavuconazole is the first listed.
NCT01651325 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01651325 about?
NCT01651325 is a clinical study titled "Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects". The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.
What is the current status of trial NCT01651325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-05. Estimated completion is 2012-05.
What conditions does trial NCT01651325 study?
This clinical trial studies the following conditions: Pharmacokinetics of Isavuconazole, Healthy Adult Volunteers, Pharmacokinetics of Dextromethorphan.
What interventions are being tested in trial NCT01651325?
The interventions under investigation include: Isavuconazole (DRUG), dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT01651325?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01651325 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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