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

An Exploratory Phase I Study in Healthy Volunteers of GI Transit Following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)

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 Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Drug: Placebo; Drug: Solabegron (GW427353)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
colonic emptying rate by radiolabeled scintigraphy	throughout the study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 16, 2006
• First Submitted That Met QC Criteria: November 16, 2006
• First Posted (Estimate): November 20, 2006

Study Record Updates

• Last Update Posted (Estimate): October 16, 2008
• Last Update Submitted That Met QC Criteria: October 15, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: tolerability; pharmacokinetics; GW427353; b3-Adrenergic Receptor Agonist; Irritable Bowel Syndrome (IBS); gastrointestinal transit
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Solabegron
• Other Study ID Numbers: B3I106248

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No