Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-28 @ 10:46 PM
Study NCT ID:
NCT06418620
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Safety, Tolerability, and Bioavailability of Orally Administered Venglustat in Healthy Adult Participants
Sponsor:
Sanofi
Organization:
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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1228-9121 | REGISTRY | ICTRP | View |