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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: solabegron and oxybutynin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Absorption rate of solabegron and oxybutynin

Secondary outcome: To assess bladder function


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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

Locations and Contacts

GSK Investigational Site, Tacoma, Washington 98418, United States
Additional Information

Starting date: June 2007
Last updated: April 14, 2015

Page last updated: August 23, 2015

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