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Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

NCT02650479 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-01-27

No results posted yet for this study

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

Conditions

  • Healthy Adult Male and Female Volunteers

Interventions

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

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02650479 on ClinicalTrials.gov