This study aims to characterize the single dose pharmacokinetics of PF-04950616 following subcutaneous injection to the abdomen, upper arm or the thigh.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
75
Single 150 mg PF-04950615 dose administered SC to the abdomen
Single 150 mg PF-04950615 dose administered SC to the upper arm
Single 150 mg PF-04950615 dose administered SC to the thigh
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Miami Research Associates
South Miami, Florida, United States
MRA Clinical Research, LLC
South Miami, Florida, United States
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Maximum Observed Plasma Concentration (Cmax)
Maximum observed concentration.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time for maximum observed concentration.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Apparent Clearance (CL/F)
Apparent clearance following subcutaneous administration.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
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Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Apparent Volume of Distribution (Vz/F)
Apparent volume of distribution following subcutaneous administration.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Terminal Elimination Half-Life (t1/2)
Terminal elimination half-life following subcutaneous administration.
Time frame: Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.
Maximum Low-density Lipoprotein Cholesterol LDL-C Lowering Effect (Emax): Absolute Value
Maximum LDL-C response using absolute on trial LDL-C data
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
Emax: Change From Baseline
LDL-C Emax expressed as change from baseline.
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
Emax: Percent Change From Baseline
LDL-C Emax expressed as percent change from baseline.
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
Time to Reach Maximum LDL-C Lowering (Tmax, LDL-C)
Time to LDL-C Emax
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
Area Under the LDL-C Effect Curve (AUEC): Absolute Value
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed using absolute on trial value
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
AUEC: Change From Baseline
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed as change from baseline
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
AUEC: Percent Change From Baseline
AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 expressed as percent change from baseline.
Time frame: Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination
Number of Participants With Injection Site Reactions (ISRs) by Severity
Acute injection site reactions (e.g, pain, pruritus, induration) were captured as adverse events (AEs). Intensity of the AE was described as mild (does not interfere with usual function), moderate (interferes to some extent with usual function), or severe (interferes significantly with participant's usual function).
Time frame: Day 1 to Day 85
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
A participant is ADA positive if ADA titer (log2) \>=6.23. A participant is nAb positive if nAb titer (log2) \>=4.32.
Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination
Anti-Drug Antibody (ADA) Titer
ADA titer: titers were presented as log2 reciprocal dilution at assay cutpoint.
Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination
Neutralizing Antibody (nAb) Titer
nAb titer: titers were presented as log2 reciprocal dilution at assay cutpoint.
Time frame: Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination