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COMPLETED
NCT06568861
PHASE1

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

Sponsor: Aligos Therapeutics

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-01-13

Completion Date

2025-07-28

Last Updated

2026-08-05

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

ALG-097558

Multiple doses of ALG-097558 200 mg (2 x 100 mg tablets)

Locations (2)

University of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States