A Phase I, Placebo Controlled, Randomised, Double Blind Two-way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.

GlaxoSmithKline0 sitesNovember 2007

ConditionsHealthy Subjects

DrugsGW842166X

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: GlaxoSmithKline
Primary Endpoint: • Heat pain threshold at 5 hours post dose
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female subjects aged 18 to 50 years inclusive
•Body Weight \>50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
•Women who are not of child bearing potential

Exclusion Criteria

•The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
•A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
•Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
•Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.