Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01565720
The ClinicalTrials.gov registry entry for NCT01565720 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (67% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Healthy Volunteers
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.
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
RECRUITING · Phase 1
-
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
RECRUITING · Phase 1
-
Classroom Break, Cognition, and Fitness in Elementary School Children
RECRUITING · Phase 1
-
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
RECRUITING · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.