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

Launched by PRINCIPIA BIOPHARMA, A SANOFI COMPANY · May 30, 2024

Keywords

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Gender

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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.

Trial Officials