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

Exclusion Criteria

• •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)
• •Blood donation, any volume, within 1 month before inclusion
• •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
• •Any medication (including St John's Wort or ginseng) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of aspirin/ibuprofen, hormonal contraception, and menopausal hormone replacement therapy
• •Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion:
• •* 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
• •Positive pregnancy test
• •Gilbert's Syndrome
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.