Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: rilzabrutinib SAR444671
* Drug: rilzabrutinib SAR444671
* Drug: rilzabrutinib SAR444671


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants will receive caplets after fast (treatment A) on Day 1 and caplets after meal (treatment B) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. | Drug: rilzabrutinib SAR444671<br>* Pharmaceutical form: caplet Route of administration: oral<br>Drug: rilzabrutinib SAR444671<br>* Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral<br>Drug: rilzabrutinib SAR444671<br>* Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral<br>|
| Experimental: Group 2<br>Participants will receive caplets after meal (treatment B) on Day 1 and caplets after fast (treatment A) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. | Drug: rilzabrutinib SAR444671<br>* Pharmaceutical form: caplet Route of administration: oral<br>Drug: rilzabrutinib SAR444671<br>* Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral<br>Drug: rilzabrutinib SAR444671<br>* Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax | maximun plasma concentration | From Day 1 to Day 7 | 
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax | time to maximum plasma concentration | From Day 1 to Day 7 | 
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last | area under the plasma concentration-time curve from zero to the last measurable concentration | From Day 1 to Day 7 | 
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf | area under the plasma concentration-time curve from zero to infinity | From Day 1 to Day 7 | 
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life | terminal elimination phase half-life | From Day 1 to Day 7 | 
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax | maximun plasma concentration | From Day 11 to Day 12 | 
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax | time to maximum plasma concentration | From Day 11 to Day 12 | 
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last | area under the plasma concentration-time curve from zero to the last measurable concentration | From Day 11 to Day 12 | 
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf | area under the plasma concentration-time curve from zero to infinity | From Day 11 to Day 12 | 
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life | terminal elimination phase half-life | From Day 11 to Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent AE and treatment-emergent SAE |  | Until Day 15 |