A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218

NCT05844228 | Completed Phase 1 FDA Drug

• 1 other identifier: VIR-2218-V108
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218

  5 days

• Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218

  5 days

• Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218

  5 days

• Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218

  5 days

• Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218

  5 days

• Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218

  5 days

Secondary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Up to 12 weeks

Study Arms (2)

Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants

EXPERIMENTAL

Drug: VIR-2218

Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 matched healthy participants

EXPERIMENTAL

Drug: VIR-2218

Interventions

VIR-2218 DRUG

VIR-2218 given by subcutaneous injection

Also known as: Elebsiran

Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants; Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 matched healthy participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have stable renal function as defined by less than 20% change in estimated glomerular filtration rate (eGFR) between the first and second screening sample with the first screening visit occurring within 28 days prior to dosing on Day 1 and the second screening visit occurring no more than 14 days apart, but at least 72 hours apart from the first.
• Body mass index (BMI) within the range 18.5 to 40.0 kg/m\^2 at screening.
• Female and Male participants must consent to follow contraception requirements
• Capability of giving signed informed consent form
• Must be in the opinion of the investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
• Must have normal renal function as defined by eGFR ≥ 90 mL/min/1.73m\^2 based on the Modification of Diet in Renal Disease (MDRD) equation determined from the mean of two measurements of serum creatinine at screening.
• 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
• Participants with RI must have chronic moderate or severe RI and be clinically stable per investigator assessment for at least 3 months prior to screening
• Moderate RI as defined by eGFR level 30-59 mL/min/1.73m\^2 based on the MDRD equation, or
• Severe RI as defined by eGFR level 15-29mL/min/1.73m\^2 based on the MDRD equation

You may not qualify if:

• Any clinically significant medical condition or psychiatric condition that may interfere with study intervention
• Participants with uncontrolled hypertension, asthma, and/or diabetes (Type I or II).
• Participants with diabetes
• Participants with any active malignancy
• Participants with vasculitis or conditions associated with vasculitis.
• Participants who have undergone major surgery within 12 months of screening
• Participants with unstable cardiac functions, abnormality, or clinically significant heart failure
• Participants with infection of HIV, HAV, HBV, HCV, HDV, or HEV
• Participants with signs of active infection
• History of bone marrow or solid organ transplantation
• Participants with end-stage renal disease or nephrotic syndrome as defined by: participants requiring hemodialysis or peritoneal dialysis, participants who have undergone or are listed for transplant, or participants who have chronic kidney disease with nephrotic syndrome
• Participants with active nephritis
• Participants with clinically significant liver disease
• History of drug or alcohol abuse
• Unwillingness or inability to follow procedures outlined in protocol

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead

Study Sites (3)

Inland Empire Clinical Trials

Rialto, California, 92377, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 21, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (3)