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A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218 - Trial NCT05844228

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.

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NCT05844228
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05844228
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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

Study Focus

Renal Impairment

VIR-2218

Interventional

drug

Sponsor & Location

Vir Biotechnology, Inc.

Rialto,Miami Lakes,Orlando, United States of America

Timeline & Enrollment

Phase 1

Jun 01, 2023

Nov 24, 2024

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT05844228

Non-Device Trial