Last updated: 11/04/2018 05:41:25

A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers

GSK study ID
B3I106248
Clinicaltrials.gov ID
NCT00401479
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: An Exploratory Phase I Study in Healthy Volunteers of GI Transit following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)
Trial description: This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the emptying of the colon and increases total colonic transit time.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

colonic emptying rate by radiolabeled scintigraphy

Timeframe: throughout the study

Secondary outcomes:

Safety and tolerability: ECG, vital signs, adverse events, clinical lab tests. Diary card collection of stool frequency Stool consistency and ease of passage Blood levels of GW427353

Timeframe: throughout the study

Interventions:
  • Drug: Placebo
  • Drug: Solabegron (GW427353)
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Irritable Bowel Syndrome (IBS)
    Product
    solabegron
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to June 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    Yes
    • Subjects with no evidence of current or past history suggestive of gastrointestinal disease or disorder or medical illness that could compromise interpretation of the study.
    • no clinically significant laboratory results collected at the screening visit
    • Females who are nursing or pregnant.
    • history of inflammatory bowel disease
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with no evidence of current or past history suggestive of gastrointestinal disease or disorder or medical illness that could compromise interpretation of the study.
    • no clinically significant laboratory results collected at the screening visit -men: body weight greater than or equal to 50kg (110 lbs)
    • women: body weight greater than or equal to 45kg (100 lbs)
    • BMI between 18.5
    • 35 kg/m2
    Exclusion criteria:
    • Females who are nursing or pregnant.
    • history of inflammatory bowel disease
    • history of gastric ulcers within 12 months of signing the informed consent form
    • tobacco users

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Rochester, Minnesota, United States, 55905
    Status
    Study Complete
    Contact us

    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
    2007-15-06

    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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