The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.
Intravenous, normal saline
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Dallas, Texas, United States
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.
Time frame: Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).
Time frame: Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
Time frame: Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.
Time frame: Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.
Time frame: From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.
Time frame: Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).
Time frame: Screening up to Day 168
Mean change from baseline and placebo in body temperature.
Time frame: Screening up to Day 168
Area under the concentration-time curve from zero to infinite time postdose (AUCinf).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
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Time to maximum concentration (Tmax).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Maximum concentration (Cmax).
Time frame: 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).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Terminal elimination half-life (t½).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Clearance (CL).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Volume of distribution (Vz).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168