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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT01981499

Run by

Pfizer

People needed

31

Starts

2014-01-01

Expected to finish

2014-04-01

Last updated by the study team

2014-05-08

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.