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

Vir Biotechnology

Status and phase

Enrolling

Phase 1

Conditions

Renal Impairment

Treatments

Drug: VIR-2218

Study type

Interventional

Funder types

Industry

Identifiers

NCT05844228

VIR-2218-V108

Details and patient eligibility

About

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

Full description

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

Enrollment

32 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)