RecruitingPhase 1NCT07342881

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

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


Sponsor

Aligos Therapeutics

Enrollment

30 participants

Start Date

Feb 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This pharmacokinetics study is examining how a drug called pevifoscorvir (ALG-000184) — being developed for hepatitis B — moves through the body in people with impaired kidney function compared to healthy individuals. Understanding this is important before using the drug more broadly. **You may be eligible if...** - You are 18–75 years old with a BMI between 17.5–40 and weigh more than 50 kg - You are either a healthy person with normal kidney function, OR someone with any degree of kidney impairment (not due to acute nephritic syndrome) - If female, you are not of childbearing potential, or you and your partner agree to use highly effective contraception - If in the kidney impairment group, your condition and medications have been stable for at least 28 days **You may NOT be eligible if...** - You have acute kidney disease (acute nephritic syndrome) - Your other health metrics (ECG, vital signs, labs) do not meet the study criteria - You are pregnant or at risk of pregnancy without contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPevifoscorvir Sodium (ALG-000184)

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


Locations(2)

Orlando Clinical Research Center

Orlando, Florida, United States

Genesis Clinical Trials

Tampa, Florida, United States

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NCT07342881


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