The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various degrees of renal impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
Participants will receive olpasiran by subcutaneous (SC) injection.
Inland Empire Clinical Trials, LLC
Rialto, California, United States
CRSCA HC LLC, dba Creekside Post Acute
Yucaipa, California, United States
Clinical Pharmacology Of Miami, LLC
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Maximum Observed Serum Concentration (Cmax) of Olpasiran
Time frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran
Time frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran
Time frame: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran
Time frame: Pre-Dialysis, 0.5, 1, 3 hours after the start of Dialysis, and immediately following the end of Dialysis, Day 1, Day 4
Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])
Time frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Maximum Inhibitory Effect (Imax) of Plasma Lp(a)
Time frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Time to Reach Imax of Lp(a)
Time frame: Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations
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Orlando Clinical Research Center
Orlando, Florida, United States
Nucleus Network - Minneapolis
Saint Paul, Minnesota, United States
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 85