Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342700
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2024-03-18
Brief Title:
A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Open-label Single-dose 4-period 4--sequence Crossover Phase I Relative Bioavailability Study Comparing Crystalline Formulation Tablet Versus Reference Amorphous Formulation Tablet of Rilzabrutinib SAR444671 in Fasted and Fed Conditions in Healthy Male and Female Participants
Status:
COMPLETED
Status Verified Date:
2024-04
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 cross-over Phase 1 4-arm study The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age
The total study duration per participant is expected to be up to 36 days including
Screening up to 4 weeks
Treatment periods once successfully screened enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods
Washout One day washout is planned after each treatment period hence providing 2 days between doses
Safety follow-up participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit ie on Day 8 of the study
The total study duration per participant is expected to be up to 36 days including
Screening up to 4 weeks
Treatment periods once successfully screened enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods
Washout One day washout is planned after each treatment period hence providing 2 days between doses
Safety follow-up participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit ie on Day 8 of the study
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 |
|---|---|---|---|
| U1111-1299-1906 | REGISTRY | ICTRP | None |