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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Page 1 of 1 (3 locations)

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