NCT00401479

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

First QC Date

November 16, 2006

Last Update Submit

October 15, 2008

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

GW427353b3-Adrenergic Receptor AgonistIrritable Bowel Syndrome (IBS)pharmacokineticstolerabilitygastrointestinal transit

Outcome Measures

Primary Outcomes (1)

  • colonic emptying rate by radiolabeled scintigraphy

    throughout the study

Secondary Outcomes (1)

  • 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

Interventions

PlaceboDRUG
Solabegron (GW427353)DRUG
Also known as: Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

solabegron

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 20, 2006

Study Start

October 1, 2006

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

US(1)