A Study To Investigate The Effect Of Solabegron (GW427353... | NCT00401479

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

NCT00401479

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

Placebo
Solabegron (GW427353)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 16, 2006

First Submission Date that Met QC Criteria

Nov 16, 2006

First Posted Date

Nov 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug
Solabegron (GW427353)	Drug			Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
colonic emptying rate by radiolabeled scintigraphy		throughout the study

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided