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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolebrutinib | Small molecule | — | Oral |