Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
NCT ID: NCT05484206
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
144 participants
INTERVENTIONAL
2022-09-21
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated first
All participants in Cohort 1 will be receiving VIR-2218 monotherapy.
VIR-2218
VIR-2218 given by subcutaneous injection.
Cohort 2: CPT-C (severe HI) participants and matched healthy participants
This arm is optional based on Cohort 1. All participants in Cohort 2 will be receiving VIR-2218 monotherapy.
VIR-2218
VIR-2218 given by subcutaneous injection.
Cohort 3: CPT-A (mild HI) participants and matched healthy participants
This cohort is optional. All participants in Cohort 3 will be receiving VIR-2218 monotherapy.
VIR-2218
VIR-2218 given by subcutaneous injection.
Cohort 4: CPT-A (mild HI) participants and matched healthy participants
All participants in Cohort 4 will be receiving VIR-3434 monotherapy.
VIR-3434
VIR-3434 given by subcutaneous injection.
Cohort 5: CPT-B (moderate HI) participants and matched healthy participants
All participants in Cohort 5 will be receiving VIR-3434 monotherapy.
VIR-3434
VIR-3434 given by subcutaneous injection.
Cohort 6: CPT-C (severe HI) participants and matched healthy participants
This arm is optional based on Cohort 5. All participants in Cohort 6 will be receiving VIR-3434 monotherapy.
VIR-3434
VIR-3434 given by subcutaneous injection.
Cohort 7: CPT-A (mild HI) and matched healthy participants
All participants in Cohort 7 will be receiving VIR-3434 and VIR-2218 combination therapy.
VIR-2218
VIR-2218 given by subcutaneous injection.
VIR-3434
VIR-3434 given by subcutaneous injection.
Cohort 8: CPT-B (moderate HI) and matched healthy participants
All participants in Cohort 8 will be receiving VIR-3434 and VIR-2218 combination therapy.
VIR-2218
VIR-2218 given by subcutaneous injection.
VIR-3434
VIR-3434 given by subcutaneous injection.
Cohort 9: CPT-C (severe HI) and matched healthy participants
This arm is optional based on Cohort 8. All participants in Cohort 9 will be receiving VIR-3434 and VIR-2218 combination therapy.
VIR-2218
VIR-2218 given by subcutaneous injection.
VIR-3434
VIR-3434 given by subcutaneous injection.
Interventions
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VIR-2218
VIR-2218 given by subcutaneous injection.
VIR-3434
VIR-3434 given by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
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Locations
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Inland Empire Clinical Trials
Rialto, California, United States
Orange County Research Center
Tustin, California, United States
CenExel Research Centers of America
Hollywood, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Texas Liver Institute
San Antonio, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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VIR-2218-V107
Identifier Type: -
Identifier Source: org_study_id
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