Skip to main content
OpenTrials
Completed

NCT Number: NCT04748926

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Adelaide, 5000, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rilzabrutinib SAR444671

Drug

Pharmaceutical form: caplet Route of administration: oral

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. Treatment-emergent AE and treatment-emergent SAE

    Time frame: Until Day 15

Sponsors and collaborators

Lead sponsor

Principia Biopharma, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.