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Completed
NCT05481411
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
Conditions: Hepatic Impairment
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 25
Sponsor: Amgen
Location: Inland Empire Clinical Trials, LLC Rialto California
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Male or female participants of nonchildbearing potential, between 18 and 75 years of age (inclusive) at the time of Screening.
* Body mass index between 18.0 and 40.0 kg/m\^2 (inclusive) at the time of Screening.
Participants with Normal Hepatic Function Only:
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee).
Participants with Hepatic Impairment Only:
• Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings.
Exclusion Criteria:
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
* Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2 (Groups 1-3) or \< 50 mL/min/1.73m\^2 (Group 4 only) by Modification of Diet in Renal Disease formula at Screening or Check-in.
* Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer) before receiving olpasiran.
* Participants who were previously exposed to olpasiran.
* Female participants with a positive pregnancy test at Screening or Check-in.
Participants with Normal Hepatic Function Only:
* Positive hepatitis panel. Participants whose results are compatible with prior immunization may be included.
* Alanine aminotransferase and aspartate aminotransferase elevations \> 3x upper limit of normal at Screening or Check-in.
Participants with Hepatic Impairment Only:
* Positive for hepatitis B surface antigen. Participants with positive hepatitis B core antibody may be included if hepatitis B surface antigen is negative. Participants with positive hepatitis B surface antibody may be included (consistent with prior vaccination).
* Active malignancy of any type. Participants with a history of malignancy that has been eradicated with supporting medical documentation indicating that there is no residual malignancy detected in the past 2 years will be allowed.
* Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).
Source: ClinicalTrials.gov (NCT05481411). StuddyBuddy aggregates publicly available trial information.