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

Part of paid clinical trials in Rialto, California.

Sponsor
Vir Biotechnology, Inc.
Study ID
NCT05484206
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cirrhosis
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • VIR-2218 — DRUG
    VIR-2218 given by subcutaneous injection.
  • VIR-3434 — DRUG
    VIR-3434 given by subcutaneous injection.

Study Details

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.

Key Dates

Start date
Sep 21, 2022
Status verified
Jun 2025
Primary completion
Sep 25, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • Experimental: Cohort 4: CPT-A (mild HI) participants and matched healthy participants
    All participants in Cohort 4 will be receiving VIR-3434 monotherapy.
  • Experimental: Cohort 5: CPT-B (moderate HI) participants and matched healthy participants
    All participants in Cohort 5 will be receiving VIR-3434 monotherapy.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218 [ Time Frame: 5 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Inland Empire Clinical TrialsRialtoCalifornia92377
Amanda Benavides
[email protected]
909-883-2999
Orange County Research CenterTustinCalifornia92790
Melanie Goerlitz
[email protected]
714-550-9990
CenExel Research Centers of AmericaHollywoodFlorida33024-
Floridian Clinical ResearchMiami LakesFlorida33016
Julio Lopez
[email protected]
305-330-9977
Texas Liver InstituteSan AntonioTexas78215-

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Inland Empire Clinical Trials· Rialto, CAOrange County Research Center· Tustin, CACenExel Research Centers of America· Hollywood, FLFloridian Clinical Research· Miami Lakes, FLTexas Liver Institute· San Antonio, TX

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