Last updated: 11/04/2018 11:16:09

Study to Test Safety, Tolerability and Blood Levels of GSK971086 after 1 Dose & 7 Days of Dosing in Healthy Adult Males

GSK study ID
SAR109935
Clinicaltrials.gov ID
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, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK971086 after a Single Dose and 7 Days of Repeat Dosing in Healthy Adult Male Volunteers
Trial description: This research study is the first administration of GSK971086 in humans. The purpose of this study is to assess the safety and tolerability of GSK971086, as well as, how much GSK971086 is in your blood after different doses
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Adverse events:

Timeframe: all visits

hematology, clinical chemistry, urinalysis:

Timeframe: Part A Days -2,2,3,14,28 & Part B Days -2,2,5,8,14,21,35

vital signs & 12-lead ECGs:

Timeframe: Part A Days -2-3,7,28 & Part B Days -2-9,14,35

Secondary outcomes:

GSK 971086 Plasma blood level:

Timeframe: art A Days 1,2,3,7,14,21,28 & Part B Days 1-9,14,21,28,35

PBone & muscle biomarkers:

Timeframe: Part A Days 1,2,7,14,21,28 & Part B Days 1,3,8,14,21,28,35

Interventions:
  • Drug: placebo
  • Drug: GSK971086
  • Enrollment:
    126
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    GSK971086
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to April 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Males between 18 and 50 years of age (inclusive), at the time of signing the informed consent form.
    • Healthy, as determined by the Investigator, based on medical evaluations performed during the Screening Period including medical history, physical examination, clinical laboratory tests, and cardiac monitoring.
    • Subjects with a history of clinically significant endocrine, gastrointestinal, hepatic,cardiovascular, neurological, haematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
    • Subjects with a history at any time in the past of coronary artery disease, congestive heart failure, angina, myocardial infarction, any cardiac surgery, valvular heart disease, clinically significant arrhythmia, dyspnea, pulmonary edema, stroke, or transient ischemic attack. ECG exclusion criteria as defined in the protocol.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    EVANSVILLE, Indiana, United States, 47714
    Status
    Study Complete

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-28-04

    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

    Additional information
    Not applicable
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