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

August 2, 2026 updated by: Aligos Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
      • Tampa, Florida, United States, 33603
        • Genesis Clinical Trials

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for All Subjects:

  1. Male and Female between 18 and 75 years old
  2. Body Mass Index (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

Inclusion Criteria for Subjects with Normal Renal Function:

  1. 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
  2. Subjects must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
  3. Normal renal function (estimated Glomerular Filtration Rate [eGFR] ≥90 mL/min) with no known or suspected renal impairment

Inclusion Criteria for Subjects with Impaired Renal Function:

  1. Subject satisfies the eGFR criteria for renal impairment classification within 28 days of study drug administration
  2. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
  3. Stable concomitant medications for the management of an individual subject's medical history for at least 28 days prior to screening
  4. Subjects must have a 12-lead ECG and vital signs assessment that meet the protocol criteria

Exclusion Criteria for All Subjects:

  1. 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
  2. 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.
  3. Subjects with a history of clinically significant drug allergy
  4. Subjects with a recent (within 1 year of randomization) history or current evidence of drug abuse or recreational drug use
  5. Excessive use of alcohol defined as regular consumption of ≥14 units/ week for women and ≥21 units/week for men
  6. Unwilling to abstain from alcohol use for 48 hours prior to start of the study through end of study follow up
  7. Subjects with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
  8. Subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >2x upper limit of normal (ULN)
  9. Subjects with bilirubin (total, direct) >1.5x ULN (unless Gilbert's is suspected)
  10. Positive pregnancy test; females must not be pregnant at enrollment

Exclusion Criteria for Subjects with Normal Renal Function:

1. Hemoglobin <10 g/dL

Exclusion Criteria for Subjects with Impaired Renal Function:

  1. Participants requiring hemodialysis and/or peritoneal dialysis
  2. Hemoglobin <9 g/dL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Subjects with Severe Renal Impairment
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
Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)
Experimental: Subjects with Normal Renal Function
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
Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)
Experimental: Subjects with Mild Renal Impairment (Optional)
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
Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)
Experimental: Subjects with Moderate Renal Impairment (Optional)
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
Multiple doses of ALG-097558 300 mg (3 x 100 mg tablets)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
C0 [Predose]
Time Frame: Pre-dose (-0.75 hours) up to Day 8
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pre-dose (-0.75 hours) up to Day 8
Area Under the Concentration Time Curve [AUC]
Time Frame: 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
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
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
Minimum Plasma Concentration [Cmin]
Time Frame: 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
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
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
Maximum Plasma Concentration [Cmax]
Time Frame: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Half-life [t1/2]
Time Frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Time to Maximum Plasma Concentration [Tmax]
Time Frame: Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post last dose on day 1 ; Pre-dose (-0.75), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6
Apparent Clearance (CL/F)
Time Frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Apparent Volume of Distribution (V/F)
Time Frame: Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in plasma
Pre-dose (-0.75 hours), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours post last dose on day 6 only
Total Amount of Drug Excreted in Urine (Ae)
Time Frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose
Renal Clearance (CLr)
Time Frame: Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose.
Pharmacokinetic parameters of ALG-097558 and metabolite ALG-097730 in urine
Collection intervals: 0-6, 6-12, 12-24, 24-36 and 36-48 hours after the last dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 20 Days
The number and severity of treatment emergent events in subjects with renal impairment and subjects with normal renal function as assessed by DAIDS v2.1 (July 2017)
Up to 20 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aligos Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALG-097558-703 / DMID 24-0022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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