Albiglutide Thorough ECG Study in Healthy Volunteers

GlaxoSmithKline94 enrolled

Overview

This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

AlbiglutideBIOLOGICAL

once weekly subcutaneous injection

MoxifloxacinDRUG

oral tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or nonpregnant, nonlactating female * Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values * BMI is ≥18 kg/m2 and ≤30 kg/m2 * Nonsmoker Exclusion Criteria: * Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus * History of arrythmia or use of antiarrhythmic agents * History of any anaphylactic reaction to any drug * History of significant cardiovascular or pulmonary dysfunction * Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis * History of alcohol or substance abuse * History of GI surgery that could influence gastric emptying * Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy * History of pancreatitis

Outcomes

Primary Outcomes

QTc interval

Measurement of cardiac repolarization after albiglutide dosing

Time frame: 6 weeks

Secondary Outcomes

QTc interval

Measurement of cardiac repolarization after albiglutide dosing

Time frame: Day 4

QT interval

Determination of the effect of moxifloxacin on cardiac repolarization

Time frame: Day -1 and Day 40

Number of participants with adverse events

Time frame: 6 weeks

Data from ClinicalTrials.gov

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