drugset / Trial / NCT06444204

A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)

NCT06444204

Phase 1 Completed 29 enrolled Principia Biopharma, a Sanofi Company
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.

Timeline

Start
2020-11-02
Primary completion
2021-03-23
Completion
2021-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule Oral

Indications