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

Principia Biopharma

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Rilzabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06444191

PRN1008-023 (Other Identifier)

PKM17089 (Other Identifier)

U1111-1260-4452 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.