Electrophysiological Effects of a Single 10 μg Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

NCT00672399 · Completed

Last updated 2026-05-28

This clinical trial tested whether a single 10 microgram dose of the medication exenatide affects the heart's electrical activity, measured by the QT interval on an electrocardiogram, in healthy adult volunteers compared to a placebo.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind basic-science study

Participants 70 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2008-04 · est. completion 2008-07

Where 2 sites · United Kingdom

What this study is testing ClinicalTrials.gov NCT00672399 ↗

Description as written by the study sponsor.

This Phase 1, randomized, three period, placebo- and positive-controlled,double-blind, double-dummy, crossover study will be performed with approximately 80 healthy male and female subjects. The effects of single doses of exenatide (10 μg, subcutaneous), moxifloxacin (400 mg, oral) or placebo(subcutaneous or oral) on QT interval will be assessed.

Treatments tested

exenatide also known as Byetta Drug

Subcutaneously injected, 10 mcg, single doses
Moxifloxacin Drug

oral, 400 mg tablet, single doses
Placebo Drug

Subcutaneously injucted in an amount equivalent to exenatide; or orally as a tablet identical in appearance to Moxifloxacin. Both are single doses

Main thing measured	Comparison of exenatide's effect on QT interval when compared to placebo
Sponsor	AstraZeneca
Conditions studied	Healthy Subjects
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00672399 ↗