Study of VIR-2218 and VIR-3434 in People with Liver Impairment
This study is looking at how two investigational drugs, VIR-2218 and VIR-3434, are handled by the body and how safe they are in people with liver impairment (cirrhosis). You might receive a single dose of VIR-2218, VIR-3434, or a combination of both. Researchers will measure the levels of these drugs in your blood to understand how your body processes them. To join, you must be between 18 and 70 years old, have a healthy kidney function (eGFR ≥ 60 mL/min), and a BMI between 18.5 and 40 kg/m2. The study aims to understand how these drugs work in people with different levels of liver impairment.
- Study design
- This interventional study plans to enroll 144 participants in different groups, but participants are not randomly assigned to a group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for drug levels in the blood are taken up to 5 days after receiving the study drug.
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NCT05484206
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
Recruiting
PHASE1Ages 18–70InterventionalTreatmentVir Biotechnology, Inc.
~144 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:VIR-2218VIR-3434
At a glance
Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218
Measured over 5 days
+5 more outcomes measured
Conditions
Where it's being run
5 sites across 3 statesCalifornia2
Florida2
Texas1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
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
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
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
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
What this trial measures
- Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR22185 days
- Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR22185 days
- Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR22185 days
- Maximum observed Plasma concentration (Cmax) of VIR-343418 weeks
- Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-343418 weeks
- Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-343418 weeks