This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
133
Single SC Injection
Single Subcutaneous Injection(s)
Single Subcutaneous Injection(s)
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline up to Day 85/169 or Early Termination (ET)
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Time frame: Baseline up to Day 85/169 or Early Termination (ET)
Change From Baseline in Heart Rate
Time frame: Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
Time frame: Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline, Day 1 to 85/169 or ET
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Time frame: Baseline, Day 1 to 85/169 or ET
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single Intravenous Infusion
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Subcutaneous Injection(s)
Single Subcutaneous Injection(s)
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
Single Intravenous Infusion
Single Intravenous Infusion
Pfizer Investigational Site
Kalamazoo, Michigan, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Time frame: Day1 pre-dose to Day 85/169 or ET
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: Day1 pre-dose to Day 85/169 or ET
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day1 pre-dose to Day 85/169 or ET
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day1 pre-dose to Day 85/169 or ET
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: Day1 pre-dose to Day 85/169 or ET
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: Day1 pre-dose to Day 85/169 or ET
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Day1 pre-dose to Day 85/169 or ET
Absolute Bioavailability (%F)
Time frame: Day1 pre-dose to Day 85/169 or ET