NCT07342881 · Aligos Therapeutics
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
What this study is about
This is a Phase 1 non-randomly assigned, where both patients and doctors know the treatment given, 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.
View original scientific description
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.
Interventions
DRUG
Pevifoscorvir Sodium (ALG-000184)
Pevifoscorvir Sodium (ALG-000184) Single oral doses of 100 mg pevifoscorvir sodium
Primary outcome measures
Area under the concentration time curve [AUC]
Time frame: Up to 4 days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Maximum plasma concentration [Cmax]
Time frame: Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Minimum plasma concentration [Cmin]
Time frame: Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
C0 [predose]
Time frame: Up to 4 days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Half-life [t1/2]
Time frame: Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Time to maximum plasma concentration [Tmax]
Time frame: Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Apparent Clearance (CL/F)
Time frame: Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Apparent Volume of Distribution (V/F)
Time frame: Up to 4 Days
Plasma PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Total Amount of Drug Excreted in Urine (Ae)
Time frame: Up to 4 Days
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Renal Clearance (CLr)
Time frame: Up to 4 Days
Urine PK parameters in each cohort of total ALG-001075 and the metabolite ALG-000302
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Orlando, Florida
- Tampa, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations