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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Cetirizine; Histamine; Histamine phosphate

Criteria

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 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).