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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Exenatide

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

IV Exenatide (therapeutic and supratherapeutic concentrations)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

IV Placebo (matching volume of placebo)

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Oral Moxifloxacin (400 mg)

Interventions

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Exenatide

IV Exenatide (therapeutic and supratherapeutic concentrations)

Intervention Type DRUG

Moxifloxacin

Oral Moxifloxacin (400 mg)

Intervention Type DRUG

Placebo comparator

IV Placebo (matching volume of placebo)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Is overtly healthy, as determined by medical history and physical examination
* Has body mass index (BMI) between 25 and 35 kg/m2
* Has fasting serum glucose \<110 mg/dL
* Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start
* Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start

Exclusion Criteria

* Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being
* Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval \>450 ms.
* Family history of sudden death
* Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes