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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04748926




Registration number
NCT04748926
Ethics application status
Date submitted
3/02/2021
Date registered
10/02/2021

Titles & IDs
Public title
Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
Scientific 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
Secondary ID [1] 0 0
U1111-1260-4526
Secondary ID [2] 0 0
PKM17098
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rilzabrutinib SAR444671
Treatment: Drugs - rilzabrutinib SAR444671
Treatment: Drugs - rilzabrutinib SAR444671

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.

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.


Treatment: Drugs: rilzabrutinib SAR444671
Pharmaceutical form: caplet Route of administration: oral

Treatment: Drugs: rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral

Treatment: Drugs: rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax
Timepoint [1] 0 0
From Day 1 to Day 7
Primary outcome [2] 0 0
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax
Timepoint [2] 0 0
From Day 1 to Day 7
Primary outcome [3] 0 0
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last
Timepoint [3] 0 0
From Day 1 to Day 7
Primary outcome [4] 0 0
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf
Timepoint [4] 0 0
From Day 1 to Day 7
Primary outcome [5] 0 0
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life
Timepoint [5] 0 0
From Day 1 to Day 7
Primary outcome [6] 0 0
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax
Timepoint [6] 0 0
From Day 11 to Day 12
Primary outcome [7] 0 0
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax
Timepoint [7] 0 0
From Day 11 to Day 12
Primary outcome [8] 0 0
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last
Timepoint [8] 0 0
From Day 11 to Day 12
Primary outcome [9] 0 0
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf
Timepoint [9] 0 0
From Day 11 to Day 12
Primary outcome [10] 0 0
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life
Timepoint [10] 0 0
From Day 11 to Day 12
Secondary outcome [1] 0 0
Treatment-emergent AE and treatment-emergent SAE
Timepoint [1] 0 0
Until Day 15

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/05/2021
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Principia Biopharma, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04748926