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Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

CompletedPhase 1

Sponsor: Principia Biopharma, a Sanofi Company

Conditions: Healthy Volunteers

Interventions: rilzabrutinib SAR444671, rilzabrutinib SAR444671, rilzabrutinib SAR444671

Countries: Australia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Adelaide, Australia