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Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants

Renal Impairment Clinical Trial

Official title:
An Open-label, Multi-center Phase 1 Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Oral Dose in Participants With Renal Impairment and in Matched Participants With Normal Renal Function

Clinical Trial 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.

Clinical Trial Description

The total duration of the study per participant will be up to 38 days including: - A screening period of up to 4 weeks. - A 5-day, open-label treatment period. - Up to 7 days post-treatment follow-up period ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05282030
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date March 23, 2022
Completion date August 2, 2022
View Details
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