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Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.
This study has been terminated.
Study NCT00536497   Information provided by GlaxoSmithKline
First Received: September 25, 2007   Last Updated: April 14, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.