Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

Launched by VIR BIOTECHNOLOGY, INC. · Jul 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two medications, VIR-2218 and VIR-3434, to see how they are processed in the body and their safety for people with liver problems, specifically those with cirrhosis. The researchers will give participants a single dose of either medication or a combination of both to understand how these treatments work and how well they are tolerated. The trial is currently recruiting participants aged 18 to 70 who have specific liver conditions classified as mild to severe, according to the Child-Pugh-Turcotte score, which helps assess liver function.

To be eligible, participants should be in reasonably good health overall, with stable liver issues and no serious heart problems or other significant health concerns. Throughout the study, participants can expect medical evaluations to ensure their safety, and they will be monitored for any side effects after receiving the treatment. It's important to note that certain individuals, such as those with severe liver disease, recent heart issues, or those on specific medications, will not be able to participate. This trial aims to improve our understanding of how these new drugs can help people with liver impairment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must be ≥18 to ≤70 years of age at screening
• • Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg/m2
• • All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation
• • Inclusion criteria: Healthy matched participants
• • Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
• • Inclusion criteria: Hepatic impaired participants
• • Apart from hepatic insufficiency, participants must, in the opinion of the Investigator be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations
• • Participant is considered to have chronic, stable moderate, severe, mild HI (of any etiology excluding chronic HBV and HDV) and has been clinically stable per Investigator assessment for at least 1 month prior to screening
• • CPT score of 5 to 6 for mild HI at screening
• • CPT score 7-9 for moderate HI at screening
• • CPT score 10-15 severe HI at screening
• Exclusion Criteria:
• • Participants with unstable cardiac function or evidence of previous myocardial infarction in the past 12 months or any clinically significant active cardiovascular disease that, in the opinion of the Investigator, could interfere with the safety of the participant
• • Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)
• • Infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), HBV (positive HBsAg or positive hepatitis B core antibody with negative hepatitis B surface antibody), hepatitis C virus (HCV), HDV or hepatitis E virus (HEV). HCV antibody positive participants with a negative HCV RNA are eligible. HDV antibody positive participants with a negative HDV RNA are eligible
• • Exclusion criteria: Healthy matched participants
• • Systolic BP is outside the range of 90-160 mmHg, or diastolic BP is outside the range of 45-95 mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female participants or 45-100 bpm for male participants at screening
• • Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medication) within 30 days prior to D1 of study participation
• • Exclusion criteria: Participants with Hepatic impairment
• • Not on stable dose and regimen of any medication
• • Acute or worsening chronic hepatitis
• • Participants requiring paracentesis more than once a month
• • Participants with refractory encephalopathy or significant Central Nervous System
• • History of gastric or esophageal variceal bleeding within the past 6 months
• • Participants with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement
• • Presence of hepatopulmonary or hepatorenal syndrome
• • Presence of primarily cholestatic liver diseases
• • History of or currently listed for liver transplantation