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

April 14, 2015 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3C109868

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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