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Completed

NCT Number: NCT06444191

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number: 0001

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rilzabrutinib

Drug

Rilzabrutinib tablet(s) administered orally

Primary outcomes

  1. Maximum measured concentration of total rilzabrutinib in plasma (Cmax)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  2. Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  3. Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to the last measurable concentration (AUC0-last)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  4. Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  5. Area under the plasma concentration-time curve of total rilzabrutinib from zero during the dosage interval (AUC0-tau)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  6. Terminal Half-Life of total rilzabrutinib in Plasma (t1/2)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  7. Apparent Total Clearance of rilzabrutinib in the plasma after oral administration (CL/F)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  8. Apparent volume of distribution after oral administration (Vd/F)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  9. Dose proportionality of rilzabrutinib

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  10. Accumulation ratio (Rac)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

Secondary outcomes

  1. Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities

    Time frame: Up to 14 days after rilzabrutinib dosing

  2. Number of Adverse Events (AE) / Serious Adverse Events (SAE)

    Time frame: From date of signed ICF, up to 47 days

  3. Bruton's Tyrosine Kinase (BTK) Occupancy characterization

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  4. Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  5. Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  6. Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to the last measurable concentration (AUC0-last)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  7. Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  8. Area under the plasma concentration-time curve of rilzabrutinib metabolites from zero during the dosage interval (AUC0-tau)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

  9. Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2)

    Time frame: Up to 48 hours after the last rilzabrutinib dose

Sponsors and collaborators

Lead sponsor

Principia Biopharma, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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