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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (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, 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.

Detailed description

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

Conditions

• Hepatic Function Abnormal

Interventions

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

Timeline

• Start date: 2022-03-18
• Primary completion: 2022-05-24
• Completion: 2022-05-24
• First posted: 2022-03-17
• Last updated: 2025-01-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study