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

CompletedPhase 1

Sponsor: Principia Biopharma, a Sanofi Company

Conditions: Healthy Volunteers

Interventions: Rilzabrutinib

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (1)

Glendale, California, United States