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

VIR-2218-V108

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

2023-06-01

2025-05-15

2025-11-21

Recruiting

Early phase I

32

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

2024-05-03