A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:3/1/2014
Start Date:August 2013
End Date:January 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, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Crossover Dose Escalation Study With Open And Double Blind (Sponsor Open), Cohorts To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06412562 In Healthy Subjects

This study will determine the safety and tolerability of PF-06412562 given orally to healthy
volunteers. To determine the optimal dose for future studies, the concentration of the drug
over time will be determined by periodic blood samples. The rate of eye blinks will be
measured as an indicator of PF-06412562 action on the receptors of interest in the brain.


Inclusion Criteria:

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

Female subjects of non childbearing potential that meet at least one of the following
criteria:

Achieved postmenopausal status, defined as: cessation of regular menses for at least 12
consecutive months with no alternative pathological or physiological cause; and have a
serum follicle stimulating hormone (FSH) level confirming the postmenopausal status;

- Have undergone a documented hysterectomy and/or bilateral oophorectomy;

- Have medically confirmed ovarian failure.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
(including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at
time of dosing).

Any condition possibly affecting drug absorption .
We found this trial at
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Pfizer Investigational Site
New Haven, Connecticut 06504
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New Haven, CT
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