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

NCT ID: NCT00401479

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS)

Keywords

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GW427353 b3-Adrenergic Receptor Agonist Irritable Bowel Syndrome (IBS) pharmacokinetics tolerability gastrointestinal transit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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Placebo

Intervention Type DRUG

Solabegron (GW427353)

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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B3I106248

Identifier Type: -

Identifier Source: org_study_id