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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127906
• Other study ID #: B1351003
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2010
• Last updated: September 22, 2010
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Independant Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-04531083 100mg
Oral PF-04531083 100mg suspension single dose
• PF-04531083 2000mg
Oral PF-04531083 2000mg suspension single dose
• Placebo suspension
Oral Placebo suspension (matched to PF-04531083 suspension)
• Placebo tablet
Oral Placebo tablet (matched to Oxycodone)
• Oxycodone 20mg
Oral Oxycodone 20mg (Oxycontin) controlled release formulation

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.		24 hours	No
Secondary	Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours		24 hours	No
Secondary	Summary of plasma concentrations of PF-04531083		24 hours	No
Secondary	Exploratory colorimetric data collected from baseline and MED test exposure areas		24 hours	No

External Links

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