Pure Global
NCT05844228

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

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 Biotechnology, Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
VIR-2218
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Vir Biotechnology, Inc.
Location
Rialto,Miami Lakes,Orlando, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jun 01, 2023
End date
Nov 24, 2024
Enrollment
32 participants
Primary outcome

Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and its metabolite AS(N-1)3'VIR-2218,Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR-2218,Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR-2218,%fe for VIR-2218 and its metabolite AS(N-1)3'VIR-2218,Ae for VIR-2218 and its metabolite AS(N-1)3'VIR-2218,CLr for VIR-2218 and its metabolite AS(N-1)3'VIR-2218

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

ICD-10 classifications
Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05844228
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05844228 through Pure Global AI's free database. This Phase 1 trial is sponsored by Vir Biotechnology, Inc. and is currently Not yet recruiting. The study focuses on Renal Impairment. Target enrollment is 32 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.