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.”

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

Intervention(s) in this Clinical Trial

• Drug: solabegron and oxybutynin

Primary Measures

• Absorption rate of solabegron and oxybutynin
  • Time Frame: as measured by multiple blood draws after repeat dosing
    

Secondary Measures

• To assess bladder function
  • Time Frame: prior to dosing Session 1 and post dose for each session
    

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 Investigatorâ s assessment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00501267

Study ID Number: B3C109868

ClinicalTrials.gov Identifier: NCT00501267

Health Authority: United States: Food and Drug Administration