A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
- Registration Number
- NCT05844228
- Lead Sponsor
- Vir Biotechnology, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 28
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/1.73m^2 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/1.73m^2 based on the MDRD equation, or
- Severe RI as defined by eGFR level 15-29mL/min/1.73m^2 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). Use of other prescription medications or over-the-counter medications that are not for chronic conditions (with the exception of vitamins and/or hormonal contraceptive medications) including herbal products within 30 days prior to D1 of study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants VIR-2218 - Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional) VIR-2218 -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218 5 days Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218 5 days Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218 5 days Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218 5 days Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218 5 days Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218 5 days
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Up to 12 weeks
Trial Locations
- Locations (3)
Inland Empire Clinical Trials
🇺🇸Rialto, California, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States