Back to resultsA Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
solabegron and oxybutynin
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring solabegron,, oxybutynin,, healthy adults,, drug interaction
Eligibility Criteria
Inclusion Criteria:
- Healthy adult males & females ages 18-65;
- Body weight >50kg; BMI between 19-32;
- Signed and dated informed consent; QTc Interval <450 msec;
Exclusion Criteria:
- Resting blood pressure >140/90 mmHg or HR >100 at screening;
- History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
- Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
- Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
- history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
- history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
- clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Absorption rate of solabegron and oxybutynin
Secondary Outcome Measures
To assess bladder function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501267
Brief Title
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
Official Title
A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
solabegron,, oxybutynin,, healthy adults,, drug interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
solabegron and oxybutynin
Primary Outcome Measure Information:
Title
Absorption rate of solabegron and oxybutynin
Time Frame
as measured by multiple blood draws after repeat dosing
Secondary Outcome Measure Information:
Title
To assess bladder function
Time Frame
prior to dosing Session 1 and post dose for each session
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:
Healthy adult males & females ages 18-65;
Body weight >50kg; BMI between 19-32;
Signed and dated informed consent; QTc Interval <450 msec;
Exclusion Criteria:
Resting blood pressure >140/90 mmHg or HR >100 at screening;
History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment
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
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
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A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
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