A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Hepatic Impairment and in Healthy Subjects with Normal Hepatic Function

Description

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

Conditions

COVID-19

Study Overview

Study Details

Study overview

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent possible, for gender. The primary purpose of this study is to characterize the effect of hepatic impairment on the plasma pharmacokinetics of ALG-097558 following administration of multiple, twice daily (Q12H) oral (PO) doses.

A Phase 1 Non-Randomized, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Moderate Hepatic Impairment and in Healthy Subjects with Normal Hepatic Function

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects with Hepatic Impairment and in Healthy Subjects with Normal Hepatic Function

Condition
COVID-19
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Orlando

Orlando Clinical Research Center, Orlando, Florida, United States, 32809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 75 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    Yes

    Collaborators and Investigators

    Aligos Therapeutics,

    Study Record Dates

    2025-05