Albiglutide Thorough ECG Study in Healthy Volunteers

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01406262

Collaborator

(none)

Enrollment

Arms

5.8

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Biological: Albiglutide Drug: Moxifloxacin	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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)

Actual Study Start Date :

Jul 6, 2011

Actual Primary Completion Date :

Dec 29, 2011

Actual Study Completion Date :

Dec 29, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Albiglutide + moxifloxacin placebo Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40	Biological: Albiglutide once weekly subcutaneous injection
Active Comparator: Albiglutide matching placebo + 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	Drug: Moxifloxacin oral tablet

Arm

Intervention/Treatment

Active Comparator: Albiglutide + moxifloxacin placebo

Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40

Biological: Albiglutide

once weekly subcutaneous injection

Active Comparator: Albiglutide matching placebo + 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

Drug: Moxifloxacin

oral tablet

Outcome Measures

Primary Outcome Measures

QTc interval [6 weeks]
Measurement of cardiac repolarization after albiglutide dosing

Secondary Outcome Measures

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
Number of participants with adverse events [6 weeks]
Number of participants with adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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