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Bruton's Tyrosine Kinase (BTK) Inhibitor

Normal hepatic function group for Liver Dysfunction

Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 8
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 to day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of PK parameters M2: AUC
Assessment of PK parameters Tolebrutinib: AUC
Secondary outcome measures
Assessment of PK parameters M2: AUClast
Assessment of PK parameters M2: Cmax
Assessment of PK parameters Tolebrutinib: AUClast
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Normal hepatic function groupExperimental Treatment1 Intervention
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
Group II: Mild hepatic impairment groupExperimental Treatment1 Intervention
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tolebrutinib
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,164 Previous Clinical Trials
3,514,970 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,828 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05283915.
~3 spots leftby Apr 2025
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