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

GlaxoSmithKline

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Healthy Subjects

Interventions

GW842166XDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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