Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

NCT07342881 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ALG-000184-208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.

Conditions

Chronic Hepatitis B Infection

Keywords

Chronic Hepatitis B Infection

Outcome Measures

Primary Outcomes (10)

• Area under the concentration time curve [AUC]

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 days

• Maximum plasma concentration [Cmax]

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• Minimum plasma concentration [Cmin]

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• C0 [predose]

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 days

• Half-life [t1/2]

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• Time to maximum plasma concentration [Tmax]

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• Apparent Clearance (CL/F)

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• Apparent Volume of Distribution (V/F)

  Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• Total Amount of Drug Excreted in Urine (Ae)

  Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

• Renal Clearance (CLr)

  Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302

  Up to 4 Days

Secondary Outcomes (1)

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

  Up to 15 days

Study Arms (2)

Subjects with renal Impairment

EXPERIMENTAL

Subjects with renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.

Drug: Pevifoscorvir Sodium (ALG-000184)

Subjects without renal impairment

EXPERIMENTAL

Subjects without renal impairment will receive single oral doses of 100 mg pevifoscorvir sodium. Subjects will be followed up for 14 days after the administration of study drug.

Drug: Pevifoscorvir Sodium (ALG-000184)

Interventions

Pevifoscorvir Sodium (ALG-000184) DRUG

Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium

Subjects with renal Impairment; Subjects without 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, sex
• 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 recent 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

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Genesis Clinical Trials

Tampa, Florida, 33603, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aligos Therapeutics Therapeutics

CONTACT

(800) 466-6059; info@aligos.com

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 is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment (Optional Part 2) and in participants without renal impairment (Parts 1 and 2), matched for age, body weight and, to the extent possible, for sex.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 15, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (2)