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

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ClinicalTrials.gov Identifier: NCT00536497
Recruitment Status : Withdrawn (Compound terminated)
First Posted : September 27, 2007
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: GW842166X Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2007



Primary Outcome Measures :
  1. 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 :
  1. 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) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00536497


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00536497     History of Changes
Other Study ID Numbers: CBA109358
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by GlaxoSmithKline:
GW842166,
Healthy volunteers,
Inflammatory Pain.