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

Pfizer

Status and phase

Withdrawn

Phase 1

Conditions

Migraine

Treatments

Drug: PF-05180999 Tablets

Drug: Placebo Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981486

B3441008

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).