Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418620
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
A Study of the Safety Tolerability and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Phase 1 Open Label Randomized 3-sequence 3-period Single Dose Study Assessing the Effect of Food on the Bioavailability of Venglustat Tablet and Comparing the Relative Bioavailability of Venglustat Tablet Chewed Versus Tablet Swallowed Whole
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:
The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed without water Also to evaluate the safety and tolerability of a single dose tablet of venglustat under fed swallowed whole and fasted swallowed whole or chewed conditions in healthy adult participants The maximum duration for participants from screening is up to 63 days
Detailed Description:
Total study duration for participants is up to 63 days including screening up to 27 days 1 day of treatment in period 1 of 7 days washout of 3 days 1 day of treatment in period 2 of 7 days washout of 3 days 1 day of treatment in period 3 of 7 days followed by a final observation over 7 days - 2 days
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 |
|---|---|---|---|
| U1111-1228-9121 | REGISTRY | ICTRP | None |