September 25, 2007 |
April 14, 2008 |
September 2007 |
Plasma GW842166 Cmax and AUC (O-Infinity) [ Time Frame: 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) ] |
Same as current |
Complete list of historical versions of study NCT00536497 on ClinicalTrials.gov Archive Site |
Plasma GW842166 AUC (0-t), tlag,tmax and t1/2 [ Time Frame: 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) ] |
Same as current |
|
Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects. |
A 2 Part Open-Label, Randomised, Crossover Study 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 |
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. |
|
Phase I |
Interventional |
Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-availability Study |
Healthy Subjects |
Drug: GW842166X |
|
|
|
Terminated |
36 |
|
|
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.
|
Both |
18 Years to 50 Years |
Yes |
|
United States |
|
|
NCT00536497 |
|
|
GlaxoSmithKline |
|
Study Director: |
GSK Clinical Trials, MD |
GlaxoSmithKline |
|
|
GlaxoSmithKline |
April 2008 |