Actively Recruiting
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Led by Aligos Therapeutics · Updated on 2026-02-04
16
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment (Cohort 2), matched for age, body weight and, to the extent possible, for sex. The effect of hepatic impairment on the plasma pharmacokinetics of ALG-001075 will be assessed in subjects who have received single oral doses of pevifoscorvir sodium (ALG-000184).
CONDITIONS
Official Title
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and Female between 18 and 75 years old
- Body mass index (BMI) between 17.5 and 40.0 kg/m² and body weight over 50 kg (110 lb)
- Female participants must be not of childbearing potential or agree to use effective contraception if of childbearing potential
- Female participants must have a negative pregnancy test at screening
- Subjects with normal liver function must be in good general health with no significant abnormalities
- Subjects with normal liver function must match the demographics of subjects with hepatic impairment by age, body weight, and gender
- Subjects with normal liver function must have no known or suspected liver impairment
- Subjects with impaired liver function must meet Child-Pugh Class B criteria (scores 7-9) within 28 days before dosing
- Subjects with impaired liver function must have stable liver disease due to hepatocellular disease confirmed by medical history or imaging
- Subjects with impaired liver function must have stable liver impairment for at least 3 months before screening
- Subjects with impaired liver function must have stable medications for at least 28 days before screening
- Subjects must meet protocol criteria for ECG and vital signs assessments
You will not qualify if you...
- Any current or past illness that could affect study results or safety
- History of cardiac arrhythmias or risk factors for Torsade de Pointes syndrome
- Clinically significant drug allergy history
- Drug abuse or recreational drug use within 1 year before randomization
- Excessive alcohol use defined as 14 or more units per week for women and 21 or more units per week for men
- Unwillingness to abstain from alcohol from 48 hours before study start through follow-up
- Infection with Hepatitis A, B, C, E or HIV or acute infections like SARS-CoV-2, unless stable treatment criteria are met
- For normal liver function subjects: creatinine clearance below 60 mL/min/1.73 m²
- For normal liver function subjects: bilirubin levels above 1.2 times upper limit of normal unless Gilbert's syndrome suspected
- For normal liver function subjects: ALT or AST levels above 1.2 times upper limit of normal
- For normal liver function subjects: Hemoglobin grade 1 or higher
- For impaired liver function subjects: advanced ascites (Grade 3)
- For impaired liver function subjects: refractory encephalopathy
- For impaired liver function subjects: esophageal variceal bleeding within past 6 months
- For impaired liver function subjects: Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement
- For impaired liver function subjects: creatinine clearance below 60 mL/min/1.73 m²
- For impaired liver function subjects: ALT or AST levels above 5 times upper limit of normal
- For impaired liver function subjects: serum sodium below 125 mmol/L
- For impaired liver function subjects: platelet count below 50 x 10^9/L
- For impaired liver function subjects: Hemoglobin grade 2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
Research Team
J
Jen Rito
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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