NCT04748926

Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Principia Biopharma, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-07
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2021-02-10
• Last updated: 2025-09-23

Locations

1 site across 1 country: Australia