A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:5/3/2014
Start Date:November 2013
End Date:May 2014
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Placebo-Controlled, Crossover, Subject- And Investigator-Blind, Sponsor-Open Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of A Modified-Release Formulation Of PF-05180999 In Healthy Adult Subjects

PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce
vascular permeability. The purpose of this study is to evaluate the safety, tolerability,
pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in
healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.


Inclusion Criteria:

- Healthy male subjects between the ages of 18 and 55 years

- No history of clinically-relevant atopic or dermatological disease

- Positive reaction to intradermal injection of histamine

Exclusion Criteria:

- Subjects with Gilbert's disease or screening laboratory test results that deviate
from the upper and/or lower limits of the reference or acceptable range. The
exception is that all liver function tests must not exceed the upper limit of normal.

- Subjects with evidence of, or history of, hepatic disorder, including acute or
chronic hepatitis B or hepatitis C

- Intolerance to intradermal histamine injection.

- Subjects with dark skin (Part B only).
We found this trial at
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Pfizer Investigational Site
St. Paul, Minnesota 55102
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St. Paul, MN
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