Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Principia Biopharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: rilzabrutinib SAR444671

Study type: Interventional

Funder types: Industry

Identifiers

NCT04748926

PKM17098

PRN1008-25 (Other Identifier)

U1111-1260-4526 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: rilzabrutinib SAR444671

Drug: rilzabrutinib SAR444671

Drug: rilzabrutinib SAR444671

Group 2

Experimental group

Description:

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:

Drug: rilzabrutinib SAR444671

Drug: rilzabrutinib SAR444671

Drug: rilzabrutinib SAR444671