NCT00536497

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

First QC Date

September 25, 2007

Last Update Submit

February 12, 2015

Conditions

Healthy Subjects

Keywords

GW842166,Healthy volunteers,Inflammatory Pain.

Outcome Measures

Primary Outcomes (1)

  • Plasma GW842166 Cmax and AUC (O-Infinity)

    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 Outcomes (1)

  • Plasma GW842166 AUC (0-t), tlag,tmax and t1/2

    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)

Interventions

GW842166XDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight \>50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
  • Healthy as judged by a responsible physician.

You may not qualify if:

  • Positive pre-study urine screen for drugs of abuse or alcohol breath test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

2-((2,4-dichlorphenyl)amino)-N-((tetrahydro-2H-pyran-4-yl)methyl)-4-(trifluoromethyl)-5-pyrimidinecarboxamide

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 27, 2007

Study Start

September 1, 2007

Last Updated

February 16, 2015

Record last verified: 2015-02