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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 8

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

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,952 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research study inclusive of individuals below 20 years of age?

"This clinical investigation is open to individuals over 18 years and under the age of 55."

Answered by AI

What is the total number of participants being recruited for this research endeavor?

"Indeed, as per the details provided on clinicaltrials.gov, this medical research study is actively seeking participants. The trial was first listed on March 25th, 2024 and underwent its latest update on April 10th, 2024. Specifically, it aims to enroll a total of 28 individuals at one designated site."

Answered by AI

Has the crystalline fasted version of SAR444671 Treatment B been authorized by the FDA?

"Power's evaluation rates the safety of Treatment B, SAR444671 crystalline fasted, at level 1 due to its Phase 1 status with restricted evidence backing its safety and effectiveness."

Answered by AI

Are prospective participants currently able to enroll in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively enrolling participants. Initially shared on March 25th, 2024, the trial has been recently updated as of April 10th, 2024. The research aims to recruit a total of 28 individuals from one designated site."

Answered by AI

Is it possible for me to participate in this medical study?

"The trial seeks to enroll 28 healthy individuals aged between 18 and 55 who meet specific requirements. These include refraining from tobacco, nicotine, or alcohol use during the study period, testing negative for drugs/alcohol at screening and check-in, avoiding certain fruits prior to treatment initiation until discharge, maintaining a body weight within specified limits based on gender, having a BMI in the range of 18.0 to 32.0 kg/m2 , ensuring normal laboratory parameters unless deemed clinically insignificant by the Investigator Hepatic transaminases levels should not exceed 1.25 times ULN; total bilirubin should stay under"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

2024. "A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06342700.

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