A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: solabegron and oxybutynin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
The purpose of this study is to determine the effect of repeat doses of solabegron and
oxybutynin when taken alone or together
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Absorption rate of solabegron and oxybutynin
Secondary outcome: To assess bladder function
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Investigational Site, Tacoma, Washington 98418, United States
Additional Information
Starting date: June 2007
Last updated: April 14, 2015
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