Status:
COMPLETED
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00401479
Start Date
October 1 2006
Last Update
October 16 2008
Active Locations (1)
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1
GSK Investigational Site
Rochester, Minnesota, United States, 55905