Dose Response and Efficacy of GW842166 in Pain

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.

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.

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.