A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
Phase 1
Completed
- Conditions
- Irritable Bowel Syndrome (IBS)
- Registration Number
- NCT00401479
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method colonic emptying rate by radiolabeled scintigraphy throughout the study
- Secondary Outcome Measures
Name Time Method 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 throughout the study
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Rochester, Minnesota, United States