Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444191
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Pharmacokinetics PK of Rilzabrutinib PRN1008 in Healthy Japanese and Caucasian Subjects
Sponsor:
Principia Biopharma a Sanofi Company
Organization:
Sanofi
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1260-4452 | REGISTRY | None | None |
| PRN1008-023 | OTHER | None | None |
| PKM17089 | OTHER | Sanofi Identifier | None |