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

• Status: Not yet recruiting
• Trial end date: 2024-11-24
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vir Biotechnology, Inc.

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)