Clinical trial NCT06444191: Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
Official title: A Phase 1, Single-Center, Open-Label Study to Evaluate the Pharmacokinetics and Tolerability of Rilzabrutinib (PRN1008) in Japanese and Caucasian Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-06-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-dose and multiple doses study to assess the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the tolerability of rilzabrutinib in Japanese and Caucasian Healthy Male and Female subjects.


Eligibility criteria: Inclusion Criteria:

* Japanese subjects must have both biological parents and all four grandparents of Japanese ancestry and born in a Japanese country of origin.
* Caucasian subjects must have four Caucasian grandparents (Hispanics of white race can be considered Caucasian).
* Healthy adult male or non-pregnant non-lactating females, 18 to 75 years of age (inclusive) at the time of screening.
* Body mass index (BMI) ≥18 and ≤35 (kg/m2), inclusive, and a minimum body weight of 45 kg.

Additional inclusion criteria might apply.

Exclusion Criteria:

* Symptoms consistent with COVID-19 such as fever, cough, and shortness of breath within 14 days before Day 1.
* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at screening or check-in (Day -1).
* Known previous COVID-19 infection.
* Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within the 7 days or 5 half-lives, whichever is longer, prior to the first study drug administration. Use of hormonal contraception is allowed prior to and during the study.

Additional exclusion criteria might apply.

Primary outcomes:
measure: Maximum measured concentration of total rilzabrutinib in plasma (Cmax)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to the last measurable concentration (AUC0-last)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Area under the plasma concentration-time curve of total rilzabrutinib from zero during the dosage interval (AUC0-tau)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Apparent volume of distribution after oral administration (Vd/F)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Dose proportionality of rilzabrutinib
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Accumulation ratio (Rac)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
Secondary outcomes:
measure: Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
timeFrame: Up to 14 days after rilzabrutinib dosing
measure: Number of Adverse Events (AE) / Serious Adverse Events (SAE)
timeFrame: From date of signed ICF, up to 47 days
measure: Bruton's Tyrosine Kinase (BTK) Occupancy characterization
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to the last measurable concentration (AUC0-last)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Area under the plasma concentration-time curve of rilzabrutinib metabolites from zero during the dosage interval (AUC0-tau)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
measure: Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)
timeFrame: Up to 48 hours after the last rilzabrutinib dose
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Investigational Site Number: 0001
state: California
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: