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CompletedNCT01127906Updated Sep 23, 2010

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

A Phase 1 interventional study of PF-04531083 100mg and PF-04531083 2000mg in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-09-23.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy Volunteers
  • cross-over
  • randomized
  • placebo and active controlled
  • heat pain
  • UVB-Induced pain model
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Other
    Randomized cross-over sequence

    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

  • 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

06

What researchers measure

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

07

Study locations

1 site
  • Pfizer Investigational Site
    Bruxelles, B-1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01127906
Lead sponsor
Pfizer
First posted
May 21, 2010
Start date
Jun 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 23, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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