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

Effect of Liver Impairment on Investigational Medication

Not Recruiting
18 years - 79 years
All
Phase 1
10 participants needed

Study Overview

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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatic Function Abnormal
  • Age: 18 years - 79 years
  • Gender: All

Inclusion Criteria:

For participants with mild hepatic impairment

  • Stable chronic liver disease assessed by medical history, physical examination, and laboratory values
  • Child-Pugh total score ranging from 5 to 6, inclusive.
  • Laboratory parameters within the acceptable range for participants with hepatic impairment; however, estimated glomerular filtration rate (eGFR) should be above or equal to 60 mL/min

For all participants

  • Body weight between 50.0 and 115.0 kg, inclusive, if male, between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) within the range 18 to 40 kg/m2, inclusive, at screening.
  • Participant with platelet count ≥150 000/μL at the screening visit and at Day -1

Exclusion Criteria:

For all participants :

  • Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥30 mmHg within 3 minutes when changing from supine to standing position at screening and Day -1
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
  • History of drug or alcohol abuse within 1 year before inclusion.
  • Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization.
  • Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
  • Use of any herbal medicines 2 weeks before IMP administration
  • Treatment with a strong or moderate CYP3A inhibitors, a strong, moderate or mild CYP2C8 inhibitors OR CYP3A, CYP2C8 inducers within 14 days before the study treatment administration or 5 half-lives, whichever is longer

Specific for participants with mild hepatic impairment:

  • Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic, renal, infectious disease, moderate or severe hepatic impairment (Child-Pugh total score greater than or equal to 7), or signs of acute illness.
  • Hepatocarcinoma.
  • Acute liver disease.
  • Hepatic encephalopathy Grade 2, 3, and 4.
  • Esophageal bleeding which is caused by esophageal varices within 3 months before inclusion.

NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Updated on 04 Apr 2025. Study ID: NCT05283915

This study investigates how mild liver impairment affects the body's processing of an investigational medication. The study involves male and female participants aged 18 to 79 years. It looks at pharmacokinetics, which is how the drug moves through the body, as well as safety and tolerability. Participants are divided into two study arms: those with normal liver function and those with mild liver impairment.

Participants will undergo several procedures, including medical history reviews, physical exams, and laboratory tests. The study includes a screening period, a treatment phase where participants receive a single dose of the investigational medication, and a follow-up period to monitor any effects. Complex medical terms such as pharmacokinetics are explained as the study of how drugs are absorbed, distributed, metabolized, and excreted by the body.

  • Who can participate: Participants aged 18 to 79 years with stable chronic liver disease and a Child-Pugh score of 5 to 6 can join. All participants must have a body weight and BMI within specified ranges and a platelet count of at least 150,000/μL.
  • Study details: Participants will receive a single dose of an investigational medication and will be monitored for safety and how the body processes the medication. A placebo is not used in this study.
  • Study timelines: The study will last up to 41 days.