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

Irritable Bowel Syndrome (IBS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401479
• Other study ID #: B3I106248
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2006
• Last updated: October 15, 2008
• Start date: October 2006

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)

Intervention

Drug:
• Placebo

• Solabegron (GW427353)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colonic emptying rate by radiolabeled scintigraphy		throughout the study
Secondary	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