A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults

• Status: Withdrawn
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999 administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be evaluated in blood and blister fluid.

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

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Healthy male and/or female (of non-childbearing potential) subjects between the ages of 18 and 55 years

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

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.

• Subjects with very light skin or very dark skin (at the discretion of the investigator).