CompletedPhase 1

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

United States16 participantsStarted 2025-01-13

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and Female between 18 and 75 years old
. BMI 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3 .Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy
. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment
. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
. Normal hepatic function with no known or suspected hepatic impairment
. Subject satisfies the criteria for Class B of the Child-Pugh classification (Child Pugh Scores 7-9 points) within 28 days of study drug administration

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Concentration Time Curve [AUC]

Timeframe: AUC(0-12): Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on days 1 and 6; AUC(0-last): Predose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12h post last dose on day 1 and 6, and additionally 14, 24, 36 and 48h on day 6 only

Time to Maximum Plasma Concentration [Tmax]

Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1; Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6

Maximum Plasma Concentration [Cmax]

Minimum Plasma Concentration [Cmin]

Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only

C0 [Predose]

Timeframe: Pre-dose (-0.75 hours) up to Day 8

Half-life [t1/2]

Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6 only

Trial details

NCT IDNCT06568861

SponsorAligos Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-16

Results submitted2026-06-12

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and Female between 18 and 75 years old
. BMI 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb) 3 .Female subjects must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any non-sterile, male sexual partners agree to use highly effective contraceptive therapy
. Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment
. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
. Normal hepatic function with no known or suspected hepatic impairment
. Subject satisfies the criteria for Class B of the Child-Pugh classification (Child Pugh Scores 7-9 points) within 28 days of study drug administration

What they're measuring

Area Under the Concentration Time Curve [AUC]

Time to Maximum Plasma Concentration [Tmax]

Maximum Plasma Concentration [Cmax]

Minimum Plasma Concentration [Cmin]

Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 6 only

C0 [Predose]

Timeframe: Pre-dose (-0.75 hours) up to Day 8

Half-life [t1/2]

Timeframe: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24, 36, and 48 hours post last dose on day 6 only

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria