Status:
COMPLETED
Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01797796
Start Date
April 1 2013
End Date
July 1 2013
Last Update
August 20 2013
Active Locations (1)
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1
Pfizer Investigational Site
Brussels, Belgium, B-1070