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

NCT01127906 | Completed Phase 1

• 1 other identifier: B1351003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

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.

  24 hours

Secondary Outcomes (4)

• 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

Study Arms (1)

Randomized cross-over sequence

OTHER

Randomized unbalanced sequence of incomplete block design with replicates within sequence

Drug: PF-04531083 100mg; Drug: PF-04531083 2000mg; Drug: Placebo suspension; Drug: Placebo tablet; Drug: Oxycodone 20mg

Interventions

PF-04531083 100mg DRUG

Oral PF-04531083 100mg suspension single dose

Randomized cross-over sequence

PF-04531083 2000mg DRUG

Oral PF-04531083 2000mg suspension single dose

Randomized cross-over sequence

Placebo suspension DRUG

Oral Placebo suspension (matched to PF-04531083 suspension)

Randomized cross-over sequence

Placebo tablet DRUG

Oral Placebo tablet (matched to Oxycodone)

Randomized cross-over sequence

Oxycodone 20mg DRUG

Oral Oxycodone 20mg (Oxycontin) controlled release formulation

Randomized cross-over sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers.
• Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 23, 2010

Record last verified: 2010-09

Locations

BE (1)