Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
Lead Sponsor:
Pfizer
Conditions:
Pain
Migraine Disorders
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01511497
Start Date
October 1 2011
End Date
January 1 2013
Last Update
February 21 2013
Active Locations (3)
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1
Pfizer Investigational Site
Miami, Florida, United States, 33126
2
Pfizer Investigational Site
Miami, Florida, United States, 33134
3
Pfizer Investigational Site
Dallas, Texas, United States, 75247