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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 April 2015 |
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Main ID: |
NCT00501267 |
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Date of registration:
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13/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
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Scientific title:
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A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects. |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00501267 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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GSK Clinical Trials, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overactive Bladder
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Intervention(s)
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Drug: solabegron and oxybutynin
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Primary Outcome(s)
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Absorption rate of solabegron and oxybutynin
[Time Frame: as measured by multiple blood draws after repeat dosing]
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Secondary Outcome(s)
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To assess bladder function
[Time Frame: prior to dosing Session 1 and post dose for each session]
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Secondary ID(s)
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B3C109868
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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