Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: rilzabrutinib SAR444671

• Registration Number: NCT04748926
• Lead Sponsor: Principia Biopharma, a Sanofi Company

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

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 Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Study Start: 2021-04-07
• Primary Completion: 2021-05-21
• Study Completion: 2021-05-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	rilzabrutinib SAR444671	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.
Group 1	rilzabrutinib SAR444671	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.

Primary Outcome Measures

Name	Time	Method
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax	From Day 1 to Day 7	time to maximum plasma concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf	From Day 1 to Day 7	area under the plasma concentration-time curve from zero to infinity
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last	From Day 1 to Day 7	area under the plasma concentration-time curve from zero to the last measurable concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax	From Day 1 to Day 7	maximun plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last	From Day 11 to Day 12	area under the plasma concentration-time curve from zero to the last measurable concentration
Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life	From Day 1 to Day 7	terminal elimination phase half-life
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax	From Day 11 to Day 12	maximun plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life	From Day 11 to Day 12	terminal elimination phase half-life
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax	From Day 11 to Day 12	time to maximum plasma concentration
Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf	From Day 11 to Day 12	area under the plasma concentration-time curve from zero to infinity

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent AE and treatment-emergent SAE	Until Day 15

Trial Locations

Locations (1)

Investigational Site; 🇦🇺 Adelaide, Australia