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A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

NCT01297062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2015-04-14

Study results available
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Summary

Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.

Conditions

  • Healthy Subjects

Interventions

DRUG

Exenatide

IV Exenatide (therapeutic and supratherapeutic concentrations)

DRUG

Moxifloxacin

Oral Moxifloxacin (400 mg)

DRUG

Placebo comparator

IV Placebo (matching volume of placebo)

Sponsors & Collaborators

Principal Investigators

  • Vice President Research and Development, MD · Amylin Pharmaceuticals, LLC.

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01297062 on ClinicalTrials.gov