Overactive Bladder
Conditions
Keywords
solabegron,, oxybutynin,, healthy adults,, drug interaction
Brief summary
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
Interventions
DRUGsolabegron and oxybutynin
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absorption rate of solabegron and oxybutynin | as measured by multiple blood draws after repeat dosing |
Secondary
| Measure | Time frame |
|---|---|
| To assess bladder function | prior to dosing Session 1 and post dose for each session |
Countries
United States
Outcome results
None listed