NCT06342700

A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

A Randomized, Open-label, Single-dose, 4-period, 4--sequence, Crossover Phase I Relative Bioavailability Study Comparing Crystalline Formulation Tablet Versus Reference Amorphous Formulation Tablet of Rilzabrutinib (SAR444671) in Fasted and Fed Conditions in Healthy Male and Female Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age. The total study duration per participant is expected to be up to 36 days, including: * Screening: up to 4 weeks * Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods. * Washout: One day washout is planned after each treatment period hence providing 2 days between doses. * Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.

Conditions

• Autoimmune Disorder
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Rilzabrutinib crystalline form	Pharmaceutical form:Film coated tablet Route of administration:Oral
DRUG	Rilzabrutinib amorphous form	Pharmaceutical form:Film coated tablet Route of administration:Oral

Timeline

• Start date: 2024-03-25
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2024-04-02
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study