GLPwatch
A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects
NCT01297062 · Completed
Last updated 2026-05-28This clinical trial tests how different doses of the drug exenatide affect the heart's electrical activity in healthy volunteers.
Status Completed The study has finished.
Phase Phase 1 Checks safety and dosing in a small group.
Type Interventional (clinical trial)
Design Randomized, triple-blind study
Participants 94 people
Who can join Ages 18–65 · all sexes Healthy volunteers accepted.
Timeline Started 2011-02 · est. completion 2011-05
Where 2 sites · United States
What this study is testing ClinicalTrials.gov NCT01297062 ↗
Description as written by the study sponsor.
Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.
Treatments tested
- Exenatide Drug
IV Exenatide (therapeutic and supratherapeutic concentrations)
- Moxifloxacin Drug
Oral Moxifloxacin (400 mg)
- Placebo comparator Drug
IV Placebo (matching volume of placebo)
| Main thing measured | Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL) |
|---|---|
| Sponsor | AstraZeneca |
| Conditions studied | Healthy Subjects |
| GLP-1 drugs | exenatide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01297062 ↗