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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401479

Enrollment

Registered

2006-11-20

Start date

2006-10-31

Completion date

Unknown

Last updated

2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

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

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.

Interventions

DRUGPlacebo

DRUGSolabegron (GW427353)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
colonic emptying rate by radiolabeled scintigraphy	throughout the study

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026