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

Inclusion Criteria:

• 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
• Willing to abstain from using tobacco or nicotine-containing products or consuming alcohol from check-in (Day -1) until discharge at end-of-study visit
• Willing to abstain from taking any prescription drugs, dietary supplements, or non-prescription drugs within 14 days or 5 half-lives, whichever, is longer, prior to the first dose of study drug through the follow-up phone call. Use of hormonal contraception and aspirin (at doses of ≤2000 mg/day) or ibuprofen (at doses of ≤1200 mg/day) are allowed prior to and during the study
• Negative urine drug/alcohol testing at screening and check-in (Day -1). Screening urine drug/alcohol testing may be repeated once if deemed appropriate by the site Investigator
• Willing to abstain from consuming grapefruit, star fruit, or Seville orange-containing products from 14 days prior to first dose of study drug until discharge from the clinical study unit

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.