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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06444191
Other study ID # PKM17089
Secondary ID U1111-1260-4452P
Status Completed
Phase Phase 1
First received
Last updated
Start date January 4, 2021
Est. completion date April 12, 2021

Study information

Verified date May 2024
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date April 12, 2021
Est. primary completion date April 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Rilzabrutinib
Rilzabrutinib tablet(s) administered orally

Locations

Country Name City State
United States Investigational Site Number: 0001 Glendale California

Sponsors (1)

Lead Sponsor Collaborator
Principia Biopharma, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum measured concentration of total rilzabrutinib in plasma (Cmax) Up to 48 hours after the last rilzabrutinib dose
Primary Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax) Up to 48 hours after the last rilzabrutinib dose
Primary 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
Primary 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
Primary 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
Primary Terminal Half-Life of total rilzabrutinib in Plasma (t1/2) Up to 48 hours after the last rilzabrutinib dose
Primary Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F) Up to 48 hours after the last rilzabrutinib dose
Primary Apparent volume of distribution after oral administration (Vd/F) Up to 48 hours after the last rilzabrutinib dose
Primary Dose proportionality of rilzabrutinib Up to 48 hours after the last rilzabrutinib dose
Primary Accumulation ratio (Rac) Up to 48 hours after the last rilzabrutinib dose
Secondary Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities Up to 14 days after rilzabrutinib dosing
Secondary Number of Adverse Events (AE) / Serious Adverse Events (SAE) From date of signed ICF, up to 47 days
Secondary Bruton's Tyrosine Kinase (BTK) Occupancy characterization Up to 48 hours after the last rilzabrutinib dose
Secondary Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax) Up to 48 hours after the last rilzabrutinib dose
Secondary Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax) Up to 48 hours after the last rilzabrutinib dose
Secondary 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
Secondary 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
Secondary 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
Secondary Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2) Up to 48 hours after the last rilzabrutinib dose
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