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

NCT06444191 | Completed Phase 1 FDA Drug

• 3 other identifiers: PKM17089U1111-1260-4452PRN1008-023
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• Maximum measured concentration of total rilzabrutinib in plasma (Cmax)

  Up to 48 hours after the last rilzabrutinib dose

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

  Up to 48 hours after the last rilzabrutinib dose

• 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

• 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

• 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

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

  Up to 48 hours after the last rilzabrutinib dose

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

  Up to 48 hours after the last rilzabrutinib dose

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

  Up to 48 hours after the last rilzabrutinib dose

• Dose proportionality of rilzabrutinib

  Up to 48 hours after the last rilzabrutinib dose

• Accumulation ratio (Rac)

  Up to 48 hours after the last rilzabrutinib dose

Secondary Outcomes (9)

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

  Up to 14 days after rilzabrutinib dosing

• Number of Adverse Events (AE) / Serious Adverse Events (SAE)

  From date of signed ICF, up to 47 days

• Bruton's Tyrosine Kinase (BTK) Occupancy characterization

  Up to 48 hours after the last rilzabrutinib dose

• Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax)

  Up to 48 hours after the last rilzabrutinib dose

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

  Up to 48 hours after the last rilzabrutinib dose

Study Arms (2)

Cohort 1: Rilzabrutinib

EXPERIMENTAL

Drug: Rilzabrutinib

Cohort 2: Rilzabrutinib

EXPERIMENTAL

Drug: Rilzabrutinib

Interventions

Rilzabrutinib DRUG

Rilzabrutinib tablet(s) administered orally

Cohort 1: Rilzabrutinib; Cohort 2: Rilzabrutinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Principia Biopharma, a Sanofi Company: lead

Study Sites (1)

Investigational Site Number: 0001

Glendale, California, 91206, United States

Location

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: January 4, 2021
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: June 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)