NCT05282030

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	tolebrutinib	Pharmaceutical form: Film-coated tablets Route of administration: oral

Timeline

• Start date: 2022-03-10
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2022-03-16
• Last updated: 2025-02-06

Locations

4 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study