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Completed

NCT Number: NCT00501267

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

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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

solabegron and oxybutynin

Drug

Primary outcomes

  1. Absorption rate of solabegron and oxybutynin

    Time frame: as measured by multiple blood draws after repeat dosing

Secondary outcomes

  1. To assess bladder function

    Time frame: prior to dosing Session 1 and post dose for each session

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 16, 2007
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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