Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00536497

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: GW842166X	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-availability Study
Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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) ]

Secondary Outcome Measures:

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) ]

Estimated Enrollment:	36
Study Start Date:	September 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536497

Locations

United States, New York
GSK Clinical Trials Call Center
Buffalo, New York, United States, 14202

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	CBA109358
Study First Received:	September 25, 2007
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00536497
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GW842166,
Healthy volunteers,
Inflammatory Pain.

Study placed in the following topic categories:

Pain
Healthy

ClinicalTrials.gov processed this record on January 15, 2009