Actively Recruiting
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
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 aged 18 to 75 years
- Body mass index (BMI) between 17.5 and 40.0 kg/m^2 and body weight over 50 kg
- Female participants of childbearing potential and their male partners agree to use effective contraception
- For normal kidney function group: good general health with no significant abnormalities, matching age, weight, and sex criteria, and estimated glomerular filtration rate (eGFR) 90 mL/min or higher
- For impaired kidney function group: eGFR criteria for renal impairment met within 28 days before dosing, any stable renal impairment except acute nephritic syndrome, stable medications for at least 28 days before screening, and acceptable ECG and vital signs per protocol
You will not qualify if you...
- Any current or past illness that could influence study results or increase risk
- History of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome, or recent/unstable cardiac disease
- Clinically significant drug allergy
- History or current drug abuse or recreational drug use within 1 year
- Excessive alcohol use (over 14 units/week for women, over 21 units/week for men)
- Unwillingness to abstain from alcohol 48 hours before study start through follow-up
- Infection with hepatitis A, B, C, E, HIV-1/HIV-2, or acute infections like SARS-CoV-2
- Elevated liver enzymes (ALT or AST over twice the upper limit of normal)
- Elevated bilirubin over 1.5 times the upper limit of normal (except suspected Gilbert's syndrome)
- Positive pregnancy test or pregnancy at enrollment
- For normal kidney function group: hemoglobin less than 10 g/dL
- For impaired kidney function group: need for hemodialysis or peritoneal dialysis, hemoglobin less than 9 g/dL
AI-Screening
AI-Powered Screening
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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
CONTACT
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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