Back to resultsA Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
Primary Purpose
Irritable Bowel Syndrome (IBS)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Solabegron (GW427353)
Sponsored by
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome (IBS) focused on measuring GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), pharmacokinetics, tolerability, gastrointestinal transit
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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
colonic emptying rate by radiolabeled scintigraphy
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00401479
Brief Title
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
Official Title
An Exploratory Phase I Study in Healthy Volunteers of GI Transit Following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome (IBS)
Keywords
GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), pharmacokinetics, tolerability, gastrointestinal transit
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Solabegron (GW427353)
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
colonic emptying rate by radiolabeled scintigraphy
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
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