Last updated: 11/04/2018 05:41:13
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
GSK study ID
B3C109868
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Absorption rate of solabegron and oxybutynin
Timeframe: as measured by multiple blood draws after repeat dosing
Secondary outcomes:
To assess bladder function
Timeframe: prior to dosing Session 1 and post dose for each session
Interventions:
Drug: solabegron and oxybutynin
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Overactive Bladder
Product
solabegron
Collaborators
Not applicable
Study date(s)
June 2007 to August 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- Healthy adult males & females ages 18-65;
- Body weight >50kg; BMI between 19-32;
- 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;
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-01-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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