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Completed

NCT Number: NCT01406262

Albiglutide Thorough ECG Study in Healthy Volunteers

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

albiglutide

Biological

once weekly subcutaneous injection

moxifloxacin

Drug

oral tablet

Primary outcomes

  1. QTc interval

    Time frame: 6 weeks

    Measurement of cardiac repolarization after albiglutide dosing

Secondary outcomes

  1. QTc interval

    Time frame: Day 4

    Measurement of cardiac repolarization after albiglutide dosing

  2. QT interval

    Time frame: Day -1 and Day 40

    Determination of the effect of moxifloxacin on cardiac repolarization

  3. Number of participants with adverse events

    Time frame: 6 weeks

    Number of participants with adverse events

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 1, 2011
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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