Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment - Trial NCT04971928
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.
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Study Focus
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1
Sep 07, 2021
Nov 10, 2022
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
Data Source
ClinicalTrials.gov
NCT04971928
Non-Device Trial