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Tests treatment safety and results for Chronic Hepatitis B Infection
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
ClinicalTrials.gov ID: NCT07342881
What this study is testing
What is Pevifoscorvir Sodium (ALG-000184)?
Pevifoscorvir Sodium (ALG-000184) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic hepatitis b infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- for All people:
- 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 people must either be not of childbearing potential or if they are a woman of childbearing potential, they are only eligible if they and any...
- Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs, clinical laboratory and...
You likely can't join if
- for All people:
- people with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional...
- people with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT...
- people with a history of clinically significant drug allergy
- people 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
See the full eligibility criteria
- for All people:
- 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 people 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...
- 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
- people 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 for people 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 (people 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
- people must have a 12-lead ECG and vital signs assessment that meet the protocol criteria
- for All people:
- people 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...
- people 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...
- people with a history of clinically significant drug allergy
- people 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
- people with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
- people with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>2x upper limit of normal (ULN)
- people 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 people with Normal Renal Function: 1\. Hemoglobin \<10 g/dL Exclusion Criteria for people with Impaired Renal Function:
- Participants requiring hemodialysis and/or peritoneal dialysis
- Hemoglobin \<9 g/dL
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, Florida, United States
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, Florida, United States; Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.