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

Phase 1

Completed

• Conditions: Pain; Migraine Disorders
• Interventions: Biological: PF-04427429; Other: Normal saline

• Registration Number: NCT01511497
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF-04427429	PF-04427429	-
Placebo	Normal saline	Normal saline

Primary Outcome Measures

Name	Time	Method
Intravenous (IV) injection site reactions.	Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).	Screening up to Day 168
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.
Mean change from baseline and placebo in body temperature.	Screening up to Day 168

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Dallas, Texas, United States