Actively Recruiting
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
Led by Aligos Therapeutics · Updated on 2026-02-27
30
Participants Needed
2
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 1, non-randomized, open-label study to evaluate the pharmacokinetics, safety, and tolerability of pevifoscorvir sodium (ALG-000184) in adults aged 18 to 75 years. The study includes participants with severe renal impairment, mild to moderate renal impairment, and those with normal kidney function, matched by age, body weight, and sex. The goal is to understand how the drug behaves in the body and its safety profile across different levels of kidney function. Participants will receive a single oral dose of 100 mg pevifoscorvir sodium. Those with renal impairment and those without will both receive the same dose and be monitored for 14 days after treatment. The study is divided into parts to include subjects with varying degrees of kidney function, including an optional part for mild or moderate impairment. During the 14-day follow-up, researchers will monitor drug levels in the blood and urine, measuring key pharmacokinetic parameters such as drug concentration over time, half-life, clearance, and volume of distribution. Safety will be assessed by tracking any treatment-emergent adverse events. Overall participation will last about two weeks, with detailed clinical and laboratory evaluations to ensure close monitoring of participants' health and response to the drug.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and Female between 18 and 75 years old
- Body Mass Index (BMI) 17.5 to 40.0 kg/m^2 and total body weight greater than 50 kg (110 lb)
- Female subjects must be not of childbearing potential or use highly effective contraceptive therapy along with any non-sterile male sexual partners
- Good general health for subjects with normal renal function as shown by medical history, vital signs, lab tests, and ECG
- Demographic matching for body weight, age, and sex for subjects with normal renal function
- Normal renal function defined as estimated Glomerular Filtration Rate (eGFR) ≥90 mL/min for normal subjects
- Subjects with renal impairment must meet eGFR criteria within 28 days before dosing
- Subjects with renal impairment may have any form of renal impairment except acute nephritic syndrome
- Stable medications for medical history management for at least 28 days before screening for renal impairment subjects
- Subjects with renal impairment must have ECG and vital signs meeting protocol criteria
You will not qualify if you...
- Any current or past illness that might affect study results or increase risk with study drug
- History of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome, or recent/unstable cardiac disease
- History of clinically significant drug allergy
- Recent (within 1 year) history or current drug abuse or recreational drug use
- Excessive alcohol use exceeding 4 units/week for women or 21 units/week for men
- Unwillingness to abstain from alcohol for 48 hours before study start through follow-up
- Infection with Hepatitis A, B, C, E or HIV, or acute infections like SARS-CoV-2
- Elevated liver enzymes (ALT or AST greater than 2 times upper limit of normal)
- Elevated bilirubin (total or direct) greater than 1.5 times upper limit of normal unless suspected Gilbert's syndrome
- Positive pregnancy test or pregnant females at enrollment
- Hemoglobin less than 10 g/dL for normal renal function subjects
- Hemoglobin less than 9 g/dL for subjects with renal impairment
- Participants requiring hemodialysis or peritoneal dialysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single oral dose of 100 mg Pevifoscorvir Sodium (ALG-000184).
1 dosing visit (in-person)
Duration - 14 days
Participants are followed up for safety and pharmacokinetic assessments after dosing.
Multiple visits over 14 days for assessments
Trial Site Locations
Total: 2 locations
1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
2
Genesis Clinical Trials
Tampa, Florida, United States, 33603
Actively Recruiting
Research Team
A
Aligos Therapeutics Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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