Pharmacokinetics (PK) of Rilzabrutinib (PRN1008) in Healthy Japanese and Caucasian Subjects
NCT06444191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2024-06-05
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
Interventions
- DRUG
-
Rilzabrutinib tablet(s) administered orally
Sponsors & Collaborators
-
Principia Biopharma, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-01-04
- Primary Completion
- 2021-04-12
- Completion
- 2021-04-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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