drugset / Trial / NCT05283915

Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Participants With Normal Hepatic Function

NCT05283915

Phase 1 Completed 10 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with normal hepatic function, in male and female participants aged 18 to 79 years.

Timeline

Start
2022-03-18
Primary completion
2022-05-24
Completion
2022-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolebrutinib Small molecule Oral

Indications