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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
Sponsor:
Information provided by:
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: solabegron and oxybutynin Phase 1

Study Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Absorption rate of solabegron and oxybutynin [ Time Frame: as measured by multiple blood draws after repeat dosing ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


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
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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