Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
NCT ID: NCT04748926
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2021-04-07
2021-05-21
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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.
rilzabrutinib SAR444671
Pharmaceutical form: caplet Route of administration: oral
rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
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.
rilzabrutinib SAR444671
Pharmaceutical form: caplet Route of administration: oral
rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
Interventions
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rilzabrutinib SAR444671
Pharmaceutical form: caplet Route of administration: oral
rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Principia Biopharma, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site
Adelaide, , Australia
Countries
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Related Links
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PKM17098 Plain Language Results Summary
Other Identifiers
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U1111-1260-4526
Identifier Type: OTHER
Identifier Source: secondary_id
PRN1008-25
Identifier Type: OTHER
Identifier Source: secondary_id
PKM17098
Identifier Type: -
Identifier Source: org_study_id
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