Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.
Phase 1
Withdrawn
- Conditions
- Healthy Subjects
- Registration Number
- NCT00536497
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Body weight >50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
- Healthy as judged by a responsible physician.
Exclusion Criteria
- Positive pre-study urine screen for drugs of abuse or alcohol breath test.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Plasma GW842166 Cmax and AUC (O-Infinity) Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)
- Secondary Outcome Measures
Name Time Method Plasma GW842166 AUC (0-t), tlag,tmax and t1/2 Timepoints: Pre dose, 15 mins, 30 mins, 45 mins, 1hr, 1.5hrs, 2hrs, 2.5hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs, 48hrs, 48hr, 96hrs (post dose)