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

Aligos Therapeutics4 个研究点分布在 1 个国家目标入组 12 人开始时间: 2026年3月10日最近更新: 2026年8月21日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Aligos Therapeutics
入组人数: 12
试验地点: 4
主要终点: Area under the concentration time curve [AUC]

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•for All Subjects:
•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
•Inclusion Criteria for Subjects with Normal Renal Function:
•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
•Inclusion Criteria for Subjects with Impaired Renal Function:
•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

排除标准

•for All Subjects:
•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
•Exclusion Criteria for Subjects with Normal Renal Function:
•1. Hemoglobin <10 g/dL
•Exclusion Criteria for Subjects with Impaired Renal Function:
•Participants requiring hemodialysis and/or peritoneal dialysis
•Hemoglobin <9 g/dL

研究组 & 干预措施

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.

干预措施: Pevifoscorvir Sodium (ALG-000184) (Drug)

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.

干预措施: Pevifoscorvir Sodium (ALG-000184) (Drug)