A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder

Phase 1

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT00501267
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Absorption rate of solabegron and oxybutynin	as measured by multiple blood draws after repeat dosing

Secondary Outcome Measures

Name	Time	Method
To assess bladder function	prior to dosing Session 1 and post dose for each session

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Tacoma, Washington, United States