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

NCT06568861 | Completed Phase 1 FDA Drug

• 1 other identifier: ALG-097558-702 / DMID 24-0001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (6)

• Area under the concentration time curve [AUC]

  Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma

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

• Time to maximum plasma concentration [Tmax]

  Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma

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

• Maximum plasma concentration [Cmax]

  Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma

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

• Minimum plasma concentration [Cmin]

  Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma

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

• C0 [predose]

  Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma

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

• Half-life [t1/2]

  Pharmacokinetic parameters of ALG-07558 and metabolite ALG-097730 in plasma

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

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Up to 20 Days

Study Arms (2)

Subjects with Moderate Hepatic Impairment (Child-Pughs Class B)

EXPERIMENTAL

Subjects with moderate hepatic impairment will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Drug: ALG-097558

Subjects with Normal Hepatic Function

EXPERIMENTAL

Subjects with normal hepatic function will receive oral doses of 200 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Drug: ALG-097558

Interventions

ALG-097558 DRUG

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

Subjects with Moderate Hepatic Impairment (Child-Pughs Class B); Subjects with Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Female subjects must have a negative serum pregnancy test at screening
• 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
• A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, Fibroscan, computerized tomography scan, or magnetic resonance imaging (MRI)
• Stable hepatic impairment for at least 3 months prior to screening or second screening visit to demonstrate stability
• Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening
• Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria

You may not qualify if:

• Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
• Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
• Subjects with a history of clinically significant drug allergy
• Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
• Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
• Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up
• Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection. Subejcts with Hepatitis B infection may be eligible for moderate impairment cohort provided provided they met stable treatment criteria. Subjects with HIV infection may be eligible for moderate impairment cohort provided they met stable treatment criteria.
• Estimated creatinine clearance \<60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\] - Unless otherwise instructed by the Study Review Committee (SRC), CKD-EPI should not be corrected for subjects of African ancestry
• Bilirubin (total, direct) \>1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 1.2×ULN
• Grade ≥1 Hemoglobin
• Subjects with advanced ascites (Grade 3)
• Subjects with refractory encephalopathy as judged by the investigator.
• Subjects with esophageal variceal bleeding within the past 6 months prior to screening.
• Subjects with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.

Sponsors & Collaborators

• Aligos Therapeutics: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is non-randomized, open-label, parallel group study. Cohort 1 will enroll moderately hepatically impaired subjects and Cohort 2 will enroll subjects without hepatic impairment.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: January 14, 2025
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (2)