Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers



Status:Completed
Conditions:Chronic Pain, Migraine Headaches
Therapuetic Areas:Musculoskeletal, Neurology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:October 2011
End Date:February 2013
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers


The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and
pharmacodynamics of PF-04427429 in healthy women.


Inclusion Criteria:

- Generally healthy women, of non-child bearing potential, between the ages of 18 and
65 years, inclusive. Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including blood
pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.

- Body Mass Index (BMI) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg
(110 lbs) and 120 kg (265 lbs) inclusive.

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects
with asymptomatic, seasonal allergies at the time of dosing will not be excluded.

- Women of childbearing potential.

- History or diagnosis of ocular disease or conditions that would confound the
assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry
AMD.
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Houston, Texas 77030
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Atlantis, Florida 33462
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