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

Overactive Bladder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501267
• Other study ID #: B3C109868
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: April 14, 2015
• Start date: June 2007
• Est. completion date: August 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• solabegron and oxybutynin

Locations

Country	Name	City	State
United States	GSK Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absorption rate of solabegron and oxybutynin		as measured by multiple blood draws after repeat dosing
Secondary	To assess bladder function		prior to dosing Session 1 and post dose for each session