Overview

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

Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Mandelic Acids
Oxybutynin
Solabegron
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