Investigational Site Number: 0001
Glendale, California, 91206, United States
NCT Number: NCT06444191
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Additional inclusion criteria might apply.
Exclusion criteria
Additional exclusion criteria might apply.
Rilzabrutinib tablet(s) administered orally
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 14 days after rilzabrutinib dosing
Time frame: From date of signed ICF, up to 47 days
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Time frame: Up to 48 hours after the last rilzabrutinib dose
Principia Biopharma, a Sanofi Company
Industry
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
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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