Last updated: 11/04/2018 10:11:46

Effect Of GW501516X On How The Heart Obtains And Uses Energy

GSK study ID
PAD100964
Clinicaltrials.gov ID
NCT00318617
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A two part study to separately evaluate the effect of 4-week treatment with GW501516X relative to placebo on cardiac energetics in a randomized, single-blind, repeat dose, parallel group design in healthy male subjects
Trial description: The purpose of this study is to determine the effect of a 4-week treatment period with GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. The data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW510516X
    • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dyslipidaemias, Heart Failure
    Product
    GW501516, GW590735
    Collaborators
    Not applicable
    Study date(s)
    December 2005 to May 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    18 - 40 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Non-smoking.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Non-smoking.
    • Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches). Exclusion criteria:
    • History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease).
    • Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    PHILADELPHIA, Pennsylvania, United States, 19104
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-10-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website