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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Migraine Disorders
• Intervention / Treatment: Biological: PF-04427429; Other: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33134
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75247
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Normal saline	Other: Normal saline; Intravenous, normal saline
Experimental: PF-04427429	Biological: PF-04427429; Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.	Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).	Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.	Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.	Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.	From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.	Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).	Screening up to Day 168
Mean change from baseline and placebo in body temperature.	Screening up to Day 168

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from zero to infinite time postdose (AUCinf).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Time to maximum concentration (Tmax).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Maximum concentration (Cmax).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Terminal elimination half-life (t½).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Clearance (CL).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Volume of distribution (Vz).	Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Estimate): February 21, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Phase 1; PF-04427429
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: B0141008