Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

A Randomized, Open-label, Phase I Study to Assess the Effects of Food and Formulation on the Pharmacokinetics of a Single Dose of Rilzabrutinib (SAR444671 [Formerly PRN1008]) in Healthy Male and Female Participants

Primary Objective:

• To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects.
• To evaluate the impact of formulation on the PK of rilzabrutinib following single oral doses to healthy subjects

Secondary Objective:

- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions

The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days

Inclusion criteria :

- Participants who are overtly healthy as determined by medical evaluation

• Body mass index (BMI) within the range ≥18 and ≤31 kg/m2 (inclusive) and a minimum body weight of 45 kg.
• Female participant is eligible to participate if she is not pregnant or breastfeeding
• Male participants are eligible to participate if they agree to refrain from donating sperm and use contraception/barrier or be abstinent from intercourse

Exclusion criteria:

• COVID-19 infection, positive test result for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus antibody
• Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within 7 days
• Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
• Clinically significant abnormal in vital signs. - Any specific situation during study implementation/course that may rise ethics considerations.

The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.