NCT02650479

Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Intarcia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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).

Conditions

• Healthy Adult Male and Female Volunteers

Interventions

Type	Name	Description
DRUG	Exenatide	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).
DRUG	Placebo	6 hour IV infusion.
DRUG	Moxifloxacin	400 mg oral dose moxifloxacin within 1 min of start of infusion of exenatide
DRUG	Palonosetron	0.25 mg administered IV within 30 minutes prior to initiating the infusion of exenatide

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-01-08
• Last updated: 2017-01-27

Locations

1 site across 1 country: Netherlands