PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
An infusion lasting approximately 60 minutes
An infusion lasting approximately 60 minutes
An infusion lasting approximately 60 minutes
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 85
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)
Time frame: Day 29, 57, 85
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Day 29, 57, 85
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 29, 57, 85
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time frame: Baseline, Day 29, 57, 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported.
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Advance Outcome Management, Inc.
Garden Grove, California, United States
Collaborative Neuroscience Network, Inc
Garden Grove, California, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States
Elite Clinical Trials, Inc.
Wildomar, California, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Kendall South Medical Center, Inc.
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
...and 25 more locations
Time frame: Day 1 up to Day 141
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Day 1 up to Day 141
Number of Participants With Clinically Significant Laboratory Abnormalities
Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.
Time frame: Screening up to Day 141
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (\>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of \>=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of \>=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of \>=50% for baseline value of less than or equal to (\<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (\>) 30 to \<=60 msec and maximum increase from baseline of \>60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.
Time frame: Screening up to Day 141
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)
Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
Time frame: Day 1 up to Day 141