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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01127906

Enrollment

Registered

2010-05-21

Start date

2010-06-30

Completion date

2010-09-30

Last updated

2010-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers, cross-over, randomized, placebo and active controlled, heat pain, UVB-Induced pain model

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.

Interventions

DRUGPF-04531083 100mg

Oral PF-04531083 100mg suspension single dose

DRUGPF-04531083 2000mg

Oral PF-04531083 2000mg suspension single dose

DRUGPlacebo suspension

Oral Placebo suspension (matched to PF-04531083 suspension)

DRUGPlacebo tablet

Oral Placebo tablet (matched to Oxycodone)

DRUGOxycodone 20mg

Oral Oxycodone 20mg (Oxycontin) controlled release formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026