A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder - Full Text View

Purpose

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

Condition	Intervention	Phase
Overactive Bladder	Drug: solabegron and oxybutynin	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Overactive Bladder

Drug Information available for: Oxybutynin chloride Oxybutynin

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	24
Study Start Date:	June 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501267

Locations


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

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information


Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00501267 History of Changes
Other Study ID Numbers:	B3C109868
Study First Received:	July 13, 2007
Last Updated:	April 14, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 28, 2016