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

August 28, 2023 updated by: Vir Biotechnology, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rialto, California, United States, 92377
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Clinical Research
        • Contact:
      • Orlando, Florida, United States, 32809
        • Recruiting
        • Orlando Clinical Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for All Participants:

  • 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 35.0 kg/m2 at screening.
  • Female and Male participants must consent to follow contraception requirements
  • Capability of giving signed informed consent form

Inclusion Criteria: Additional Criteria Specific to Healthy Participants:

  • 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/1.73m2 based on the Modification of Diet in Renal Disease (MDRD) equation determined from the mean of two measurements of serum creatinine at screening.

Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment

  • 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/1.73m2 based on the MDRD equation, or
  • Severe RI as defined by eGFR level 15-29 mL/min/1.73m2 based on the MDRD equation

Exclusion Criteria: Criteria for All Participants

  • 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

Exclusion Criteria: Additional Criteria Specific to Healthy Participants

  • Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medications) including herbal products within 30 days prior to D1 of study participation

Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment

  • Not on stable dose and regimen of any medication(s) (prescription or over-the-counter) that the participants is taking regularly (eg, medications for chronic conditions such as hypertension, high cholesterol, or depression must not be changed in dose or type for at least 2 weeks prior to study drug administration)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants
Drug: VIR-2218
VIR-2218 given by subcutaneous injection
Experimental: Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional)
Drug: VIR-2218
VIR-2218 given by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
5 days
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'VIR-2218
Time Frame: 5 days
5 days
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
5 days
Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
5 days
Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
5 days
Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vir Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

November 24, 2024

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIR-2218-V108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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