Single-dose pevifoscorvir sodium in people with and without kidney problems

A Phase 1 Non-Randomized, Open-Label, 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

This test gives a single dose of pevifoscorvir sodium to people with chronic hepatitis B who have different levels of kidney function and to matched healthy volunteers to see how the drug is processed and tolerated.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Aligos Therapeutics (Industry-sponsored)
• Locations: 2 sites (Orlando, Florida and 1 other locations)
• Trial ID: NCT07342881 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, non-randomized study gives a single dose of pevifoscorvir sodium to participants with severe renal impairment (Part 1), optionally to those with mild or moderate impairment (Part 2), and to matched participants with normal renal function. Participants are matched by age, body weight and, when possible, sex to allow direct pharmacokinetic and safety comparisons across renal function groups. The study's primary focus is to measure drug concentrations over time and record safety and tolerability after a single dose. The trial is sponsored by Aligos Therapeutics and conducted at clinical research centers in Florida.

Who should consider this trial

Good fit: Adults 18–75 with chronic hepatitis B who meet the BMI and weight requirements and either have normal renal function or defined mild, moderate, or severe renal impairment and who agree to required contraceptive measures.

Not a fit: People under 18 or over 75, those with unstable medical conditions, pregnant people, or those whose kidney function falls outside the study's defined categories are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, results could guide safer dosing for people with chronic hepatitis B who have kidney impairment by clarifying how renal function affects drug levels and side effects.

How similar studies have performed: Similar pharmacokinetic comparisons across renal function groups are commonly used and have guided dosing for other hepatitis B antivirals, but pevifoscorvir's renal handling is still novel and not yet established.

Eligibility criteria

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, sex
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 recent 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

Where this trial is running

Orlando, Florida and 1 other locations

• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Genesis Clinical Trials — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Aligos Therapeutics Therapeutics

Conditions Chronic Hepatitis B Infection