The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp\[a\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Subcutaneous injection
Queen Mary Hospital
Hong Kong, HK, Hong Kong
Maximum Observed Concentration (Cmax) of Olpasiran
The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Time to Cmax (Tmax) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Terminal Elimination Half-life (T1/2) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran
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The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Apparent Total Body Clearance (CL/F) of Olpasiran
The serum PK parameters of olpasiran were calculated using standard noncompartmental methods.
Time frame: Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was defined as an AE that starts on or after the first dose of investigational product and up to end of study. Clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms, and vital signs were reported as AEs.
Time frame: Up to Day 225
Percentage Change From Baseline in Triglycerides
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Total Cholesterol
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Apolipoprotein A1 (ApoA1)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Apolipoprotein B (Apo B)
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 7, 15, 57, 155 and 225
Percentage Change From Baseline in Lipoprotein-a (Lp[a])
Participants were fasted overnight (at least 10 hours) before collection of blood samples for lipids.
Time frame: Baseline and Days 2, 4, 7, 15, 29, 57, 85, 113, 155, 183 and 225