drugset / Trial / NCT05282030
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of tolebrutinib tablets compared with normal renal function, in male and female participants aged 18 to 79 years.
Timeline
- Start
- 2022-03-10
- Primary completion
- 2022-08-02
- Completion
- 2022-08-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolebrutinib | Small molecule | — | Oral |