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

This study has been withdrawn prior to enrollment.
(Compound terminated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536497
First Posted: September 27, 2007
Last Update Posted: February 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 1

Study Type: Interventional
Study Design: 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

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) ]

Enrollment: 0
Study Start Date: September 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00536497     History of Changes
Other Study ID Numbers: CBA109358
First Submitted: September 25, 2007
First Posted: September 27, 2007
Last Update Posted: February 16, 2015
Last Verified: February 2015

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