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

NCT06698549 | Completed Phase 1 FDA Drug

• 1 other identifier: ALG-097558-703 / DMID 24-0022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal 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 renal 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 (10)

• Area under the concentration time curve [AUC]

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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

• Maximum plasma concentration [Cmax]

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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

• Minimum plasma concentration [Cmin]

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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

• C0 [predose]

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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

• Half-life [t1/2]

  Pharmacokinetic parameters of ALG-097558 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-097558 and metabolite ALG-097730 in plasma

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

• Apparent Clearance (CL/F)

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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

• Apparent Volume of Distribution (V/F)

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma

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

• Total Amount of Drug Excreted in Urine (Ae)

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

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

• Renal Clearance (CLr)

  Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine

  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 (4)

Subjects with Severe Renal Impairment

EXPERIMENTAL

Subjects with severe renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Drug: ALG-097558

Subjects with Normal Renal Function

EXPERIMENTAL

Subjects with normal renal function will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Drug: ALG-097558

Subjects with Mild Renal Impairment (Optional)

EXPERIMENTAL

Subjects with mild renal impairment will receive oral doses of 300 mg ALG-097558 twice daily (every 12 hours \[Q12H\]) for 6 days for 11 total doses.

Drug: ALG-097558

Subjects with Moderate Renal Impairment (Optional)

EXPERIMENTAL

Subjects with moderate renal impairment will receive oral doses of 300 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 300 mg (3 x 100 mg tablets)

Subjects with Mild Renal Impairment (Optional); Subjects with Moderate Renal Impairment (Optional); Subjects with Normal Renal Function; Subjects with Severe Renal Impairment

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
• Body Mass Index (BMI) 17.5 to 40.0 kg/m\^2 and a total body weight \>50 kg (110 lb)
• 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, clinical laboratory and 12-lead electrocardiogram (ECG) assessment
• Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
• Normal renal function (estimated Glomerular Filtration Rate \[eGFR\] ≥90 mL/min) with no known or suspected renal impairment
• Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration
• Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
• 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 and 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 (subjects with normal renal function) or unstable (subjects with renal impairment) 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
• Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>2x upper limit of normal (ULN)
• Subjects with bilirubin (total, direct) \>1.5x ULN (unless Gilbert's is suspected)
• Positive pregnancy test; females must not be pregnant at enrollment
• \. Hemoglobin \<10 g/dL
• Participants requiring hemodialysis and/or peritoneal dialysis
• Hemoglobin \<9 g/dL

Sponsors & Collaborators

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

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Trials

Tampa, Florida, 33603, 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. In Part 1, Cohort 1 will enroll severely renally impaired subjects and Cohort 2 will enroll subjects without renal impairment. In Part 2, if triggered, Cohort 3 will enroll mildly renally impaired subjects and Cohort 4 moderately renally impaired subjects. Cohort 5 will enroll subjects without renal impairment.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 21, 2024
• Study Start: February 1, 2025
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: October 20, 2025

Record last verified: 2024-11

Locations

US (3)