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

NCT02650479 Phase 1 COMPLETED

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

Details

Lead sponsor	Intarcia Therapeutics
Phase	Phase 1
Status	COMPLETED
Enrolment	82
Start date	2016-01
Completion	2016-04

Conditions

• Healthy Adult Male and Female Volunteers

Interventions

• Exenatide
• Placebo
• Moxifloxacin
• Palonosetron

Primary outcomes

• Pilot Study: Establishment of mean plasma steady state concentration of 500 pg/mL — 35 days
• Core Study: Changes to QTc interval changes (threshold > 10 msec) measurements — 56 days

Countries

Netherlands