The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
Subcutaneous injection
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
The Texas Liver Institute, Inc.
San Antonio, Texas, 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
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
Time frame: Up to Day 85
Number of Participants With Clinically Significant Changes 12-lead Electrocardiogram (ECG) Measurements
Time frame: Up to Day 85
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Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 85