Albiglutide Thorough ECG Study in Healthy Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406262
• Other study ID #: 107085
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2011
• Last updated: June 7, 2017
• Start date: July 6, 2011
• Est. completion date: December 29, 2011

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 29, 2011
• Est. primary completion date: December 29, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• Albiglutide
once weekly subcutaneous injection

Drug:
• Moxifloxacin
oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc interval	Measurement of cardiac repolarization after albiglutide dosing	6 weeks
Secondary	QTc interval	Measurement of cardiac repolarization after albiglutide dosing	Day 4
Secondary	QT interval	Determination of the effect of moxifloxacin on cardiac repolarization	Day -1 and Day 40
Secondary	Number of participants with adverse events	Number of participants with adverse events	6 weeks

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 107085 can be found on the GSK Clinical Study Register.