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Brachytherapy

Treatment D: SAR444671 crystalline fed for Healthy Subjects

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 8
Awards & highlights

Study Summary

This trial is testing two different formulations of a drug called rilzabrutinib in healthy male and female participants aged 18 to 55 years old. Participants will be given different doses of

Who is the study for?
Healthy men and women aged 18-55 who don't use tobacco or alcohol, avoid certain fruits, have a body weight of 50-100 kg for males and 40-90 kg for females with a BMI of 18-32. They must not take prescription drugs or supplements (with exceptions) before and during the trial.Check my eligibility
What is being tested?
The study is testing how food affects the absorption of two forms of Rilzabrutinib in healthy participants. It's a cross-over study where each person receives different treatments over time to compare results.See study design
What are the potential side effects?
Since this is an early-phase trial primarily focused on bioavailability rather than therapeutic effects, specific side effects are not detailed here but will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state
Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state
Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state
Secondary outcome measures
Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state
Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state
Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Treatment D: SAR444671 crystalline fedExperimental Treatment1 Intervention
Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fed conditions on Day 1 for one period
Group II: Treatment B: SAR444671 crystalline fastedExperimental Treatment1 Intervention
Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period
Group III: Treatment A: SAR444671 amorphous fastedActive Control1 Intervention
Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period
Group IV: Treatment C: SAR444671 amorphous fedActive Control1 Intervention
Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fed conditions on Day 1 for one period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilzabrutinib crystalline form
2024
Completed Phase 1
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SanofiLead Sponsor
2,170 Previous Clinical Trials
3,516,552 Total Patients Enrolled
~19 spots leftby Jun 2025
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