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

Primary Purpose

Renal Impairment

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VIR-2218
Sponsored by
Vir Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Inland Empire Clinical TrialsRecruiting
  • Floridian Clinical ResearchRecruiting
  • Orlando Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2023
Last Updated
August 28, 2023
Sponsor
Vir Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05844228
Brief Title
A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
Official Title
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 in Adult Participants With Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
November 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants
Arm Type
Experimental
Arm Title
Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VIR-2218
Intervention Description
VIR-2218 given by subcutaneous injection
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame
5 days
Title
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
Title
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
Title
Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame
5 days
Title
Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame
5 days
Title
Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Inland Empire Clinical Trials
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Benavides
Phone
909-883-2999
Ext
148
Email
abenavides@ieliverfoundation.com
Facility Name
Floridian Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Benites
Phone
305-330-9977
Ext
124
Email
aabenitez@floridiancr.com
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneesha Rutherford
Phone
407-472-0283
Email
arutherford@ocrc.net

12. IPD Sharing Statement

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

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