Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

Healthy Adult Male and Female Volunteers Clinical Trial

Official title: Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers

Status Completed

Clinical Trial Summary

Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers

Clinical Trial Description

This single-center Phase I study will consist of 2 parts, a Pilot Part and a Core Part.

The Pilot Part of the study will be an open-label, non-randomized, single-treatment design in 10 healthy male and female subjects to determine if an infusion regimen of a 6-h continuous IV infusion of exenatide will lead to a mean plasma steady state concentration of 500 pg/mL.

The Core part of the study will be a double-blind (except for the use of open label active control moxifloxacin), randomized, placebo-controlled,3 period, 6-sequence, cross-over design in 72 healthy male and female subjects to evaluate whether exenatide at therapeutic and supra-therapeutic concentrations has a pharmacological effect on cardiac repolarization (threshold value >10 msec). ;

Related Conditions & MeSH terms

• Healthy Adult Male and Female Volunteers

• NCT number: NCT02650479
• Study type: Interventional
• Source: Intarcia Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Completion date: April 2016