Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Principia Biopharma, a Sanofi Company24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

rilzabrutinib SAR444671DRUG

Pharmaceutical form: caplet Route of administration: oral

rilzabrutinib SAR444671DRUG

Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral

rilzabrutinib SAR444671DRUG

Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Investigational Site

Adelaide, Australia

Outcomes

Primary Outcomes

Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax

maximun plasma concentration