Albiglutide Thorough ECG Study in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Biological: Albiglutide
* Drug: Moxifloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albiglutide + moxifloxacin placebo<br>Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40 | Biological: Albiglutide<br>* once weekly subcutaneous injection<br>|
| Active Comparator: Albiglutide matching placebo + moxifloxacin<br>Once weekly subcutaneous injection of albiglutide matching placebo for 6 weeks, given with oral 400mg moxifloxacin tablet on Day -1 and moxifloxacin matching placebo on Day 40, or weekly albiglutide matching placebo for 6 weeks plus oral moxifloxacin matching placebo on Day -1 then oral 400mg moxifloxacin on Day 40 | Drug: Moxifloxacin<br>* oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval | Measurement of cardiac repolarization after albiglutide dosing | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval | Measurement of cardiac repolarization after albiglutide dosing | Day 4 | 
| QT interval | Determination of the effect of moxifloxacin on cardiac repolarization | Day -1 and Day 40 | 
| Number of participants with adverse events | Number of participants with adverse events | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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albiglutide, QT interval, cardiac repolarization, ECG study