Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

• ClinicalTrials.gov Identifier: NCT04748926
• Recruitment Status: Completed
• First Posted: February 10, 2021
• Last Update Posted: July 8, 2021
• Sponsor: Principia Biopharma, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Principia Biopharma, a Sanofi Company )

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: rilzabrutinib SAR444671	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official 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
• Actual Study Start Date: April 7, 2021
• Actual Primary Completion Date: May 21, 2021
• Actual Study Completion Date: May 21, 2021

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Treatment-emergent AE and treatment-emergent SAE [ Time Frame: Until Day 15 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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.

Contacts and Locations

Locations

Australia

Investigational Site

Adelaide, Australia, 5000

Sponsors and Collaborators

Principia Biopharma, a Sanofi Company

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Principia Biopharma, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT04748926
• Other Study ID Numbers: PKM17098; U1111-1260-4526 ( Other Identifier: UTN ); PRN1008-25 ( Other Identifier: Principia Biopharma )
• First Posted: February 10, 2021
• Last Update Posted: July 8, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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://www.clinicalstudydatarequest.com/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No