BridgeMD
Tests treatment safety and results for Chronic Hepaititis B Infections
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
ClinicalTrials.gov ID: NCT07342868
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 hepaititis b infections.
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 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).
- 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
You may be able to join if
- Male and Female between 18 and 75 years old
- 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...
- Female people must have a negative serum pregnancy test at screening for people with Normal Hepatic Function:
- Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram...
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
- Male and Female between 18 and 75 years old
- 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...
- Female people must have a negative serum pregnancy test at screening for people with Normal Hepatic Function:
- Good general health as defined by no clinically relevant abnormalities identified by Medical History and a vital signs and 12-lead electrocardiogram (ECG) assessment
- people must fit the demographic-matching criteria including body weight, age, and to the extent possible, gender
- Normal hepatic function with no known or suspected hepatic impairment for people with Impaired Hepatic Function:
- Subject satisfies the criteria for Class B of the Child-Pugh classification (Child Pugh Scores 7-9 points) within 28 days of study drug administration
- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound...
- Stable hepatic impairment for at least 3 months prior to screening or second screening visit to demonstrate stability
- 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...
- 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 history or clinical evidence at screening of significant or...
- 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 provided they met stable treatment criteria. people with HIV infection may be eligible for moderate...
- Estimated creatinine clearance \<60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula] - Unless otherwise instructed by the Study Review Committee (SRC)...
- Bilirubin (total, direct) \>1.2× upper limit of normal (ULN) (unless Gilbert's is suspected)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 1.2×ULN
- Grade ≥1 Hemoglobin Exclusion Criteria for people with Impaired Hepatic Function:
- people with advanced ascites (Grade 3)
- people with refractory encephalopathy as judged by the investigator.
- people with esophageal variceal bleeding within the past 6 months prior to screening.
- people with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement.
- Estimated creatinine clearance \<60 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula] - Unless otherwise instructed by the SRC, CKD-EPI should not be...
- ALT or AST level ≥5×ULN
- Serum sodium ≤125 mmol/L
- Platelets \<50×10\^9/L
- Grade ≥2 Hemoglobin
The study team makes the final eligibility decision.
Where it's taking place
- Orlando, 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orlando, 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.