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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Drug: Placebo; Drug: Solabegron (GW427353)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401479

B3I106248

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind