Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-06305591

Drug: Placebo

Other: Capsaicin challenge

Study type

Interventional

Funder types

Industry

Identifiers

B5281005

Details and patient eligibility

About

The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.

Enrollment

16 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male Caucasian subjects with skin type I-III inclusive (Fitzpatrick Scale), between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
An informed consent document signed and dated by the subject.
Subjects must have a distance from base of scaphoid to antecubital fossa equal of greater to 26 cm on their forearms.
Subjects who demonstrate a capsaicin -mediated neurogenic flare with a value >200 on the arbitrary Laser Doppler output at any of the time points 30, 40, 50 or 60 minutes following administration of capsaicin at Screening.

Exclusion criteria

Evidence or history of clinically significant hematological (ie, abnormalities due to prolonged exposure to altitude), renal), endocrine or dismetabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or pain condition, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessively hairy volar forearms.
History of febrile illness within 5 days prior to dosing.