A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT05481411
- Run by
- Amgen
- People needed
- 25
- Starts
- 2022-09-13
- Expected to finish
- 2023-05-31
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- 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
Full record on ClinicalTrials.gov
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