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Completed

NCT Number: NCT01127906

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04531083 100mg

Drug

Oral PF-04531083 100mg suspension single dose

PF-04531083 2000mg

Drug

Oral PF-04531083 2000mg suspension single dose

Placebo Suspension

Drug

Oral Placebo suspension (matched to PF-04531083 suspension)

Placebo Tablet

Drug

Oral Placebo tablet (matched to Oxycodone)

Oxycodone 20mg

Drug

Oral Oxycodone 20mg (Oxycontin) controlled release formulation

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.

    Time frame: 24 hours

  2. Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours

    Time frame: 24 hours

  3. Summary of plasma concentrations of PF-04531083

    Time frame: 24 hours

  4. Exploratory colorimetric data collected from baseline and MED test exposure areas

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 21, 2010
Registry last updated
Sep 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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