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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00536497

Enrollment

Registered

2007-09-27

Start date

2007-09-30

Completion date

Unknown

Last updated

2015-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

GW842166,, Healthy volunteers,, Inflammatory Pain.

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.

Interventions

DRUGGW842166X

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026