Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Hepatic Function Abnormal
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05283915
Start Date
March 18 2022
End Date
May 24 2022
Last Update
January 15 2025
Active Locations (2)
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1
Clinical Pharmacology of Miami Site Number : 8400002
Miami, Florida, United States, 33014
2
Nucleus Network Site Number : 8400001
Saint Paul, Minnesota, United States, 55114