Hepatic Function Abnormal Clinical Trial
Official title:
An Open-label Phase 1, Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Dose in Adult Participants With Mild Hepatic Impairment, and in Matched Participants With Normal Hepatic Function
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.
The total duration of the study per participant is up to 41 days including: - A screening period of up to 4 weeks (Days -28 to -2) - A 5-day, open-label treatment period - Up to 7 days post-treatment follow-up period ;