A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
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ClinicalTrials.gov Identifier: NCT00501267 |
Recruitment Status
:
Completed
First Posted
: July 16, 2007
Last Update Posted
: April 15, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overactive Bladder | Drug: solabegron and oxybutynin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | June 2007 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

- Absorption rate of solabegron and oxybutynin [ Time Frame: as measured by multiple blood draws after repeat dosing ]
- To assess bladder function [ Time Frame: prior to dosing Session 1 and post dose for each session ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501267
United States, Washington | |
GSK Investigational Site | |
Tacoma, Washington, United States, 98418 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00501267 History of Changes |
Other Study ID Numbers: |
B3C109868 |
First Posted: | July 16, 2007 Key Record Dates |
Last Update Posted: | April 15, 2015 |
Last Verified: | April 2015 |
Keywords provided by GlaxoSmithKline:
solabegron, oxybutynin, healthy adults, drug interaction |
Additional relevant MeSH terms:
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Oxybutynin Solabegron Mandelic Acids Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Urological Agents Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Adrenergic beta-3 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents |