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Albiglutide Thorough ECG Study in Healthy Volunteers

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Albiglutide

Moxifloxacin

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring albiglutide, QT interval, cardiac repolarization, ECG study

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Albiglutide + moxifloxacin placebo

Albiglutide matching placebo + moxifloxacin

Arm Description

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

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

Outcomes

Primary Outcome Measures

QTc interval

Measurement of cardiac repolarization after albiglutide dosing

Secondary Outcome Measures

QTc interval

Measurement of cardiac repolarization after albiglutide dosing

QT interval

Determination of the effect of moxifloxacin on cardiac repolarization

Number of participants with adverse events

Full Information

NCT ID

NCT01406262

First Posted

July 28, 2011

Last Updated

June 7, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01406262

Brief Title

Albiglutide Thorough ECG Study in Healthy Volunteers

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 6, 2011 (Actual)

Primary Completion Date

December 29, 2011 (Actual)

Study Completion Date

December 29, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

albiglutide, QT interval, cardiac repolarization, ECG study

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Albiglutide + moxifloxacin placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Albiglutide matching placebo + moxifloxacin

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Albiglutide

Intervention Description

once weekly subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Moxifloxacin

Intervention Description

oral tablet

Primary Outcome Measure Information:

Title

QTc interval

Description

Measurement of cardiac repolarization after albiglutide dosing

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

QTc interval

Description

Measurement of cardiac repolarization after albiglutide dosing

Time Frame

Day 4

Title

QT interval

Description

Determination of the effect of moxifloxacin on cardiac repolarization

Time Frame

Day -1 and Day 40

Title

Number of participants with adverse events

Description

Number of participants with adverse events

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

25387217

Citation

Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

107085

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

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Albiglutide Thorough ECG Study in Healthy Volunteers

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