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 |
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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