Healthy Subjects
Conditions
Keywords
mechanical pain,, heat pain,, dose,, efficacy, dose response,, GW842166,, Single,, pharmacodynamics,, repeat dose,
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.
Interventions
DRUGGW842166X
Administer
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Heat pain threshold at 5 hours post dose | 5 Hours |
Secondary
| Measure | Time frame |
|---|---|
| • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. | 5 Hours |
Outcome results
None listed