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NCT05481411 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Hepatic Impairment, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
3
Study locations

NCT05481411 is a Phase 1 study of Hepatic Impairment that has completed, run by Amgen. The registered enrollment target is 25 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (31% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT05481411, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target
3
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Olpasiran

Study Locations (3)

California

  • Inland Empire Clinical Trials, LLC - Rialto

Florida

  • Orlando Clinical Research Center - Orlando

Texas

  • The Texas Liver Institute, Inc. - San Antonio

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2022-09-13
Est. Completion 2023-05-31
Phase Phase 1

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT05481411

The ClinicalTrials.gov registry entry for NCT05481411 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (31% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Olpasiran is the first listed.

NCT05481411 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT05481411 about?

NCT05481411 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment". 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.

What is the current status of trial NCT05481411?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-09-13. Estimated completion is 2023-05-31.

What conditions does trial NCT05481411 study?

This clinical trial studies the following conditions: Hepatic Impairment.

What interventions are being tested in trial NCT05481411?

The interventions under investigation include: Olpasiran (DRUG).

Who is sponsoring clinical trial NCT05481411?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05481411 being conducted?

This trial has 3 study locations across California, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.