A Phase 1 Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Monotherapy and Combination Therapy in Adult Participants With Hepatic Impairment

  • STATUS
    Recruiting
  • End date
    Mar 20, 2024
  • participants needed
    144
  • sponsor
    Vir Biotechnology, Inc.
Updated on 20 October 2022
Accepts healthy volunteers

Summary

In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.

Description

Participants may be enrolled in Cohorts 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a non-randomized way.

Details
Condition Hepatic Impairment, Cirrhosis
Treatment VIR-2218, VIR-3434
Clinical Study IdentifierNCT05484206
SponsorVir Biotechnology, Inc.
Last Modified on20 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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