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

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

Official Title
-----------------
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

Conditions
-----------------
Pain, Migraine Disorders

Intervention / Treatment
-----------------
* Biological: PF-04427429
* Other: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1, PF-04427429