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

GlaxoSmithKline36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

PlaceboDRUG

Solabegron (GW427353)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

colonic emptying rate by radiolabeled scintigraphy

Time frame: 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

Time frame: throughout the study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.