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NCT04971928

Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment

A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of GSK3228836 in Adults With Hepatic Impairment and Healthy Matched Control Participants (B-Assured)
GlaxoSmithKline·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
GSK3228836
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Location
Orlando,San Antonio, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Sep 07, 2021
End date
Nov 10, 2022
Enrollment
48 participants
Primary outcome

Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)],Maximum observed concentration (Cmax)

Summary

This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of
 GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment),
 Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic
 function as healthy control.

ICD-10 classifications
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04971928
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04971928 through Pure Global AI's free database. This Phase 1 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 48 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.