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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: solabegron and oxybutynin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00501267

B3C109868

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)