A Phase 1, Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 in Adult Participants With Renal Impairment
Overview
- Phase
- Phase 1
- Intervention
- VIR-2218
- Conditions
- Renal Impairment
- Sponsor
- Vir Biotechnology, Inc.
- Enrollment
- 28
- Locations
- 3
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants
Intervention: VIR-2218
Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 matched healthy participants
Intervention: VIR-2218
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 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
Time Frame: 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
Time Frame: 5 days
Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
Fraction excreted in urine in percentage for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
Renal clearance for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Time Frame: 5 days
Secondary Outcomes
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)(Up to 12 weeks)