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
Drug: rilzabrutinib SAR444671
Pharmaceutical form: caplet Route of administration: oral
Drug: rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
Drug: rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
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.
Investigational Site
Adelaide, Australia
Clinical Sciences & Operations, Study Director
Sanofi