Electrophysiological Effects of a Single [amount hidden] Dose of Exenatide on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Exenatide.

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.

It had six arms (groups): Sequence 1 (experimental), Sequence 2 (experimental), Sequence 3 (experimental), Sequence 4 (experimental) and Sequence 5 (experimental).

Period 1 = placebo exenatide/placebo moxifloxacin; Period II = exenatide/placebo moxifloxacin; Period III = placebo exenatide/moxifloxacin.

Period I = exenatide/placebo moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = placebo exenatide/placebo moxifloxacin.

Period 1 = placebo exenatide/moxifloxacin; Period II = placebo exenatide/moxifloxacin; Period III = exenatide/placebo moxifloxacin.

The registry classes the interventions as drug.

Who Took Part

70 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Are between the ages of 18 and 65 years, inclusive. Have body mass index (BMI) between 19 and 35 kg/m2, inclusive.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: known allergies to exenatide or excipients, moxifloxacin or related compounds, or a history of multiple adverse drug allergies of any origin; personal history of unexplained syncope within last year; history or presence of cardiovascular (myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gi, endocrine, haematological, or neurological disorders.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-04 with completion listed for 2008-07.

It ran at 2 sites in United Kingdom (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Comparison of exenatide's effect on QT interval when compared to placebo.

It also tracked 2 secondary outcomes, for example Measurement of any QTcF changes following exenatide versus glucose, potassium, and insulin and Assessment of plasma exenatide concentrations and QTc interval.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.