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

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ClinicalTrials.gov Identifier: NCT05484206
Recruitment Status : Recruiting
First Posted : August 2, 2022
Last Update Posted : May 3, 2024
Sponsor:
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Cirrhosis Drug: VIR-2218 Drug: VIR-3434 Phase 1

Detailed Description:
Participants may be enrolled in Cohorts 1, 2, 3, 4, 5, 6, 7, 8, and 9 in a non-randomized way.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 21, 2022
Estimated Primary Completion Date : September 25, 2026
Estimated Study Completion Date : April 30, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection.
Experimental: 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.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection.
Experimental: 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.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection.
Experimental: Cohort 4: CPT-A (mild HI) participants and matched healthy participants
All participants in Cohort 4 will be receiving VIR-3434 monotherapy.
 Drug: VIR-3434
VIR-3434 given by subcutaneous injection.
Experimental: Cohort 5: CPT-B (moderate HI) participants and matched healthy participants
All participants in Cohort 5 will be receiving VIR-3434 monotherapy.
 Drug: VIR-3434
VIR-3434 given by subcutaneous injection.
Experimental: 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.
 Drug: VIR-3434
VIR-3434 given by subcutaneous injection.
Experimental: 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.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection.

Drug: VIR-3434
VIR-3434 given by subcutaneous injection.
Experimental: 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.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection.

Drug: VIR-3434
VIR-3434 given by subcutaneous injection.
Experimental: 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.
 Drug: VIR-2218
VIR-2218 given by subcutaneous injection.

Drug: VIR-3434
VIR-3434 given by subcutaneous injection.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218 [ Time Frame: 5 days ]
  2. 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'VIR2218 [ Time Frame: 5 days ]
  3. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR2218 [ Time Frame: 5 days ]
  4. Maximum observed Plasma concentration (Cmax) of VIR-3434 [ Time Frame: 18 weeks ]
  5. Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-3434 [ Time Frame: 18 weeks ]
  6. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-3434 [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Up to 18 Weeks ]
  2. Incidence of ADA and titers of ADA to VIR-3434 at each study visit for cohorts receiving VIR-3434 therapy [ Time Frame: 18 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05484206


Locations
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United States, California
Inland Empire Clinical Trials Recruiting
Rialto, California, United States, 92377
Contact: Amanda Benavides    909-883-2999    abenavides@ieliverfoundation.com   
Orange County Research Center Recruiting
Tustin, California, United States, 92790
Contact: Melanie Goerlitz    714-550-9990    Melanie.goerlitz@ocresearchcenter.com   
United States, Florida
CenExel Research Centers of America Withdrawn
Hollywood, Florida, United States, 33024
Floridian Clinical Research Recruiting
Miami Lakes, Florida, United States, 33016
Contact: Julio Lopez    305-330-9977 ext 124    jlopez@floridiancr.com   
United States, Texas
Texas Liver Institute Terminated
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Vir Biotechnology, Inc.
More Information
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT05484206    
Other Study ID Numbers: VIR-2218-V107
First Posted: August 2, 2022    Key Record Dates
Last Update Posted: May 3, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vir Biotechnology, Inc.:
siRNA
Monoclonal antibody
HDV
Compensated Cirrhosis
Decompensated Cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Fibrosis
Pathologic Processes
Digestive System Diseases