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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 | Clinical Trials | Clareo Health

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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

NCT05283915•Sanofi

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (2)

Clinical Pharmacology of Miami Site Number : 8400002

Miami, Florida, United States

Nucleus Network Site Number : 8400001

Saint Paul, Minnesota, United States

Key Dates

Start Date

March 18, 2022

Primary Completion Date

May 24, 2022

Completion Date

May 24, 2022

Last Updated

January 15, 2025

Enrollment

ACTUAL participants

Conditions

Hepatic Function Abnormal

Interventions

tolebrutinib

DRUG