Last updated: 11/07/2018 01:54:46

Albiglutide thorough ECG study in healthy volunteers

Request patient level data
GSK study ID
107085
See study documents
Clinicaltrials.gov ID
NCT01406262
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

QTc interval

Timeframe: 6 weeks

Secondary outcomes:

QTc interval

Timeframe: Day 4

QT interval

Timeframe: Day -1 and Day 40

Number of participants with adverse events

Timeframe: 6 weeks

Interventions:
  • Biological/vaccine: Albiglutide
  • Drug: Moxifloxacin
    • Enrollment:
    94
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Borje Darpo, Meijian Zhou, Jessica Matthews, Hui Zhi , Malcolm A. Young, Caroline Perry, Rickey R. Reinhardt. Albiglutide does not prolong the QTc Interval in Healthy Subjects: - A Thorough ECG Study . Diabetes Ther. 2014;5:144-153.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    July 2011 to December 2011
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • 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
    • Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
    • History of arrythmia or use of antiarrhythmic agents
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-29-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 107085 can be found on the GSK Clinical Study Register.
    Click here
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website