Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 25, 2007
Last updated: February 12, 2015
Last verified: February 2015

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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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
Intervention Details:
    Drug: GW842166X
    Other Name: GW842166X

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00536497

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00536497     History of Changes
Other Study ID Numbers: CBA109358
Study First Received: September 25, 2007
Last Updated: February 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Healthy volunteers,
Inflammatory Pain. processed this record on February 25, 2015