Trials Sponsors Conditions Drugs Pricing

Conditions

Autoimmune Disorder Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state
Cmax: maximum plasma concentration
Day 1 to Day 8
Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state
AUClast: area under the plasma concentration versus time curve from time zero to the last measurable concentration
Day 1 to Day 8
Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state
AUC: area under the plasma concentration versus time curve extrapolated to infinity
Day 1 to Day 8

Secondary Outcomes (7)

Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state
Day 1 to Day 8
Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state
Day 1 to Day 8
Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state
Day 1 to Day 8
Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state
Day 1 to Day 8
Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state
Day 1 to Day 8
+2 more secondary outcomes

Study Arms (4)

Treatment A: SAR444671 amorphous fasted

ACTIVE COMPARATOR

Participants will receive single oral dose of amorphous tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period

Drug: Rilzabrutinib amorphous form

Treatment B: SAR444671 crystalline fasted

EXPERIMENTAL

Participants will receive single oral dose of crystalline tablet formulation rilzabrutinib (SAR444671) under fasted conditions on Day 1 for one period

Drug: Rilzabrutinib crystalline form

Treatment C: SAR444671 amorphous fed

ACTIVE COMPARATOR

Interventions

Rilzabrutinib crystalline formDrug

Pharmaceutical form:Film coated tablet Route of administration:Oral

Also known as: SAR444671

Treatment B: SAR444671 crystalline fastedTreatment D: SAR444671 crystalline fed

Rilzabrutinib amorphous formDrug

Pharmaceutical form:Film coated tablet Route of administration:Oral

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive
Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant. Hepatic transaminases (aspartate aminotransferase, alanine aminotransferase) should not exceed 1.25 × the upper laboratory norm (ULN); total bilirubin should not exceed 1 × ULN

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Nucleus Network Site Number : 8400001

Saint Paul, Minnesota, 55114, United States

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Enrollment

28 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

April 2, 2024

Study Start

March 25, 2024

Actual (reported)

You may not qualify if:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), infectious disease, or signs of acute illness
Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening. Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation \[ECMO\], mechanically ventilated)
Participant has a positive test result for SARS-CoV-2 (measured via Real-time Reverse Transcriptase Polymerase Chain Reaction \[RT-PCR\] or Rapid Antigen Test \[RAT\])
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month)
Symptomatic postural hypotension, irrespective of 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
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician
History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis)
Regular intake of nicotine (via patch, smoking, vaping or other forms) more than 10 mg per day (based on the average nicotine content of 10-12 mg of nicotine per cigarette and inhalation of up to 2 mg of nicotine per cigarette), and unable to stop smoking during the study (occasional smoker can be enrolled)
Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)
If female, pregnancy (defined as positive β-HCG blood test), or breast-feeding
Non-live vaccines, including COVID-19: last administration of a vaccine within 4 weeks before randomization
Live vaccines: last administration of a vaccine within 3 months before randomization
Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab)
Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates)
Positive alcohol breath or alcohol urine test
+3 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (4)

Treatment A: SAR444671 amorphous fasted

Treatment B: SAR444671 crystalline fasted

Treatment C: SAR444671 amorphous fed

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Treatment D: SAR444671 crystalline fed

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (4)

Treatment A: SAR444671 amorphous fasted

Treatment B: SAR444671 crystalline fasted

Treatment C: SAR444671 amorphous fed

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Treatment D: SAR444671 crystalline fed

You may not qualify if:

Data Sharing

Source record

Locations