Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748926
• Other study ID #: PKM17098
• Secondary ID: U1111-1260-4526P
• Status: Completed
• Phase: Phase 1
• Start date: April 7, 2021
• Est. completion date: May 21, 2021

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• rilzabrutinib SAR444671
Pharmaceutical form: caplet Route of administration: oral
• rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
• rilzabrutinib SAR444671
Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral

Locations

Country	Name	City	State
Australia	Investigational Site	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Principia Biopharma, a Sanofi Company

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax	maximun plasma concentration	From Day 1 to Day 7
Primary	Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax	time to maximum plasma concentration	From Day 1 to Day 7
Primary	Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last	area under the plasma concentration-time curve from zero to the last measurable concentration	From Day 1 to Day 7
Primary	Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf	area under the plasma concentration-time curve from zero to infinity	From Day 1 to Day 7
Primary	Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life	terminal elimination phase half-life	From Day 1 to Day 7
Primary	Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax	maximun plasma concentration	From Day 11 to Day 12
Primary	Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax	time to maximum plasma concentration	From Day 11 to Day 12
Primary	Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last	area under the plasma concentration-time curve from zero to the last measurable concentration	From Day 11 to Day 12
Primary	Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf	area under the plasma concentration-time curve from zero to infinity	From Day 11 to Day 12
Primary	Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life	terminal elimination phase half-life	From Day 11 to Day 12
Secondary	Treatment-emergent AE and treatment-emergent SAE		Until Day 15