Albiglutide Thorough ECG Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: Albiglutide; Drug: Moxifloxacin

• Registration Number: NCT01406262
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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 Timeline

• Study Start: 2011-07-06
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-08-01
• Primary Completion: 2011-12-29
• Study Completion: 2011-12-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albiglutide + moxifloxacin placebo	Albiglutide	Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40
Albiglutide matching placebo + moxifloxacin	Moxifloxacin	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

Primary Outcome Measures

Name	Time	Method
QTc interval	6 weeks	Measurement of cardiac repolarization after albiglutide dosing

Secondary Outcome Measures

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