Dose Response and Efficacy of GW842166 in Pain
Phase 1
Withdrawn
- Conditions
- Healthy Subjects
- Registration Number
- NCT00554762
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method • Heat pain threshold at 5 hours post dose 5 Hours
- Secondary Outcome Measures
Name Time Method • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. 5 Hours