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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00401479
First received: November 16, 2006
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome (IBS)
Drug: Placebo
Drug: Solabegron (GW427353)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: An Exploratory Phase I Study in Healthy Volunteers of GI Transit Following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • colonic emptying rate by radiolabeled scintigraphy [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: October 2006
Intervention Details:
    Drug: Placebo Drug: Solabegron (GW427353)
    Other Names:
    • Placebo
    • Solabegron (GW427353)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401479

Locations
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00401479     History of Changes
Other Study ID Numbers: B3I106248
Study First Received: November 16, 2006
Last Updated: October 15, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GW427353
b3-Adrenergic Receptor Agonist
Irritable Bowel Syndrome (IBS)
pharmacokinetics
tolerability
gastrointestinal transit

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Adrenergic Agents
Solabegron
Adrenergic Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists

ClinicalTrials.gov processed this record on August 26, 2014