Study S001264

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

ClinicalTrials.gov record

Registration

Registration: NCT02650479
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 82
Start: 2016-01
Primary completion: 2016-04
Lead sponsor: Intarcia Therapeutics
Conditions: Healthy Adult Male and Female Volunteers
Interventions: DRUG:Exenatide; DRUG:Placebo; DRUG:Moxifloxacin; DRUG:Palonosetron
Results posted: FALSE
Individual participant data sharing: NO

Registered 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]

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