Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06444191
• Other study ID #: PKM17089
• Secondary ID: U1111-1260-4452P
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

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