Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

September 18, 2025 updated by: Principia Biopharma, a Sanofi Company

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
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
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
Experimental: Group 2
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax
Time Frame: From Day 1 to Day 7
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 Frame: From Day 1 to Day 7
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
Time Frame: From Day 1 to Day 7
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
Time Frame: From Day 1 to Day 7
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
Time Frame: From Day 1 to Day 7
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
Time Frame: From Day 11 to Day 12
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 Frame: From Day 11 to Day 12
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
Time Frame: From Day 11 to Day 12
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
Time Frame: From Day 11 to Day 12
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
Time Frame: From Day 11 to Day 12
terminal elimination phase half-life
From Day 11 to Day 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Treatment-emergent AE and treatment-emergent SAE
Time Frame: Until Day 15
Until Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Principia Biopharma, a Sanofi Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKM17098
  • U1111-1260-4526 (Other Identifier: UTN)
  • PRN1008-25 (Other Identifier: Principia Biopharma)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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