Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
- Registration Number
- NCT06444191
- Lead Sponsor
- Principia Biopharma, a Sanofi Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Rilzabrutinib Rilzabrutinib - Cohort 2: Rilzabrutinib Rilzabrutinib -
- Primary Outcome Measures
Name Time Method Dose proportionality of rilzabrutinib Up to 48 hours after the last rilzabrutinib dose Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F) Up to 48 hours after the last rilzabrutinib dose Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax) Up to 48 hours after the last rilzabrutinib dose Maximum measured concentration of total rilzabrutinib in plasma (Cmax) Up to 48 hours after the last rilzabrutinib dose Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to the last measurable concentration (AUC0-last) Up to 48 hours after the last rilzabrutinib dose Terminal Half-Life of total rilzabrutinib in Plasma (t1/2) Up to 48 hours after the last rilzabrutinib dose Apparent volume of distribution after oral administration (Vd/F) Up to 48 hours after the last rilzabrutinib dose Accumulation ratio (Rac) Up to 48 hours after the last rilzabrutinib dose Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) Up to 48 hours after the last rilzabrutinib dose Area under the plasma concentration-time curve of total rilzabrutinib from zero during the dosage interval (AUC0-tau) Up to 48 hours after the last rilzabrutinib dose
- Secondary Outcome Measures
Name Time Method Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities Up to 14 days after rilzabrutinib dosing Number of Adverse Events (AE) / Serious Adverse Events (SAE) From date of signed ICF, up to 47 days Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2) Up to 48 hours after the last rilzabrutinib dose Bruton's Tyrosine Kinase (BTK) Occupancy characterization Up to 48 hours after the last rilzabrutinib dose Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to the last measurable concentration (AUC0-last) Up to 48 hours after the last rilzabrutinib dose Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax) Up to 48 hours after the last rilzabrutinib dose Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax) Up to 48 hours after the last rilzabrutinib dose Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) Up to 48 hours after the last rilzabrutinib dose Area under the plasma concentration-time curve of rilzabrutinib metabolites from zero during the dosage interval (AUC0-tau) Up to 48 hours after the last rilzabrutinib dose
Trial Locations
- Locations (1)
Investigational Site Number: 0001
🇺🇸Glendale, California, United States