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

Conditions

• Hepatic Function Abnormal

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• tolebrutinib — DRUG
  Pharmaceutical form: Film-coated tablet Route of administration: oral

Study Details

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.

Key Dates

Start date

Mar 18, 2022

Status verified

Jan 2025

Primary completion

May 24, 2022

Completion

May 24, 2022

Study Design

Enrollment

10 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mild hepatic impairment group
  Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
• Experimental: Normal hepatic function group
  Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition

Primary Outcome Measure

Assessment of PK parameters Tolebrutinib: AUC [ Time Frame: From Day 1 to Day 4 ]

Locations (2)

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