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Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

NCT04748926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-23

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Principia Biopharma, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2021-05-21
Completion
2021-05-21

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04748926 on ClinicalTrials.gov