Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin

Study Overview
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Brief Summary
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PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.

Official Title
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A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-04531083 100mg
* Drug: PF-04531083 2000mg
* Drug: Placebo suspension
* Drug: Placebo tablet
* Drug: Oxycodone 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers. Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg. Exclusion Criteria: Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy). Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening). Subjects with inadequate or excessive sensitivity to UVB light.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Randomized cross-over sequence<br>Randomized unbalanced sequence of incomplete block design with replicates within sequence | Drug: PF-04531083 100mg<br>* Oral PF-04531083 100mg suspension single dose<br>Drug: PF-04531083 2000mg<br>* Oral PF-04531083 2000mg suspension single dose<br>Drug: Placebo suspension<br>* Oral Placebo suspension (matched to PF-04531083 suspension)<br>Drug: Placebo tablet<br>* Oral Placebo tablet (matched to Oxycodone)<br>Drug: Oxycodone 20mg<br>* Oral Oxycodone 20mg (Oxycontin) controlled release formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours. |  | 24 hours | 
| Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours |  | 24 hours | 
| Summary of plasma concentrations of PF-04531083 |  | 24 hours | 
| Exploratory colorimetric data collected from baseline and MED test exposure areas |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, cross-over, randomized, placebo and active controlled, heat pain, UVB-Induced pain model