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OpenTrials
Completed

NCT Number: NCT00401479

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

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.

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Solabegron (GW427353)

Drug

Other names: Placebo

Primary outcomes

  1. colonic emptying rate by radiolabeled scintigraphy

    Time frame: 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

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2006
First posted
Nov 20, 2006
Registry last updated
Oct 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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