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COMPLETED
NCT05481411
PHASE1

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment

Sponsor: Amgen

View on ClinicalTrials.gov

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.

Official title: A Phase I, Open-label Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Subjects With Various Degrees of Hepatic Impairment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-09-13

Completion Date

2023-05-31

Last Updated

2026-10-28

Healthy Volunteers

Yes

Interventions

DRUG

Olpasiran

Subcutaneous injection

Locations (3)

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