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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127906

B1351003

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 1 patient group

Randomized cross-over sequence

Other group

Description:

Randomized unbalanced sequence of incomplete block design with replicates within sequence

Treatment:

Drug: Oxycodone 20mg

Drug: PF-04531083 2000mg

Drug: Placebo suspension

Drug: PF-04531083 100mg

Drug: Placebo tablet