Clinical trial NCT04748926: Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility 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.

Primary outcomes:
measure: Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax
timeFrame: From Day 1 to Day 7
measure: Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax
timeFrame: From Day 1 to Day 7
measure: Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last
timeFrame: From Day 1 to Day 7
measure: Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf
timeFrame: From Day 1 to Day 7
measure: Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life
timeFrame: From Day 1 to Day 7
measure: Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax
timeFrame: From Day 11 to Day 12
measure: Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax
timeFrame: From Day 11 to Day 12
measure: Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last
timeFrame: From Day 11 to Day 12
measure: Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf
timeFrame: From Day 11 to Day 12
measure: Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life
timeFrame: From Day 11 to Day 12
Secondary outcomes:
measure: Treatment-emergent AE and treatment-emergent SAE
timeFrame: Until Day 15
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Investigational Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: