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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04531083 100mg; Drug: PF-04531083 2000mg; Drug: Placebo suspension; Drug: Placebo tablet; Drug: Oxycodone 20mg

• Registration Number: NCT01127906
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Study Start: 2010-06
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-22
• Last Update Posted: 2010-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomized cross-over sequence	PF-04531083 100mg	Randomized unbalanced sequence of incomplete block design with replicates within sequence
Randomized cross-over sequence	PF-04531083 2000mg	Randomized unbalanced sequence of incomplete block design with replicates within sequence
Randomized cross-over sequence	Placebo suspension	Randomized unbalanced sequence of incomplete block design with replicates within sequence
Randomized cross-over sequence	Placebo tablet	Randomized unbalanced sequence of incomplete block design with replicates within sequence
Randomized cross-over sequence	Oxycodone 20mg	Randomized unbalanced sequence of incomplete block design with replicates within sequence

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium