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NCT01565720 · ClinicalTrials.gov registry record · Phase 1
Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
A Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 161
- Enrollment target
- 1
- Study location
NCT01565720: Completed Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole, sponsored by Astellas Pharma Global Development.
NCT01565720 is a Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 161 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565720, a Phase 1 study of Healthy Volunteers and Pharmacokinetics of Isavuconazole, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 161 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups. All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on three study days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Isavuconazole
Study Locations (1)
California
- Parexel - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01565720 record still lists
NCT01565720 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01565720 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01565720 about?
NCT01565720 is a clinical study titled "Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization". This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the las...
What is the current status of trial NCT01565720?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 161 participants. The study started on 2012-03. Estimated completion is 2012-06.
What conditions does trial NCT01565720 study?
This clinical trial studies the following conditions: Healthy Volunteers, Pharmacokinetics of Isavuconazole.
What interventions are being tested in trial NCT01565720?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Isavuconazole (DRUG).
Who is sponsoring clinical trial NCT01565720?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01565720 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01565720's enrollment target sits among peer trials
161 55th of 283 higher than 229 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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