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NCT01297062 · ClinicalTrials.gov registry record · Phase 1
A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
NCT01297062: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01297062 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 94 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01297062, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
Study Summary
Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.
Primary Outcome
Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.
Interventions
- DRUG Moxifloxacin
- DRUG Exenatide
- DRUG Placebo comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2011-02 |
| Est. Completion | 2011-05 |
| Phase | Phase 1 |
What the finished NCT01297062 record still lists
NCT01297062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% higher).
The record links to 0 conditions, and to 3 interventions - of which Moxifloxacin is the first listed.
NCT01297062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01297062 about?
NCT01297062 is a clinical study titled "A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects". Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.
What is the current status of trial NCT01297062?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2011-02. Estimated completion is 2011-05.
What interventions are being tested in trial NCT01297062?
The interventions under investigation include: Moxifloxacin (DRUG), Exenatide (DRUG), Placebo comparator (DRUG).
Who is sponsoring clinical trial NCT01297062?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01297062's enrollment target sits among peer trials
94 615th of 2000 higher than 1,377 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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