Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

NCT02650479 · Completed

Last updated 2026-05-28

This clinical trial tests the effects of the drug exenatide, given through an IV, on heart rhythm in healthy adult men and women.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 82 people

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

Timeline Started 2016-01 · est. completion 2016-04

Where 1 site · Netherlands

What this study is testing ClinicalTrials.gov NCT02650479 ↗

Description as written by the study sponsor.

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

Treatments tested

Exenatide Drug

6 hour IV infusion (double infusion of 0.1250 mcg/kg/hour for 30 min followed by infusion rate (1X) of 0.0625 mcg/kg/hour for 5.5 hours).
Placebo Drug

6 hour IV infusion.
Moxifloxacin Drug

400 mg oral dose moxifloxacin within 1 min of start of infusion of exenatide
Palonosetron Drug

0.25 mg administered IV within 30 minutes prior to initiating the infusion of exenatide

Main thing measured	Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL
Sponsor	Intarcia Therapeutics
Conditions studied	Healthy Adult Male and Female Volunteers
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02650479 ↗