Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418607
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
A Study of the Safety Tolerability and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Phase 1 Open Label Randomized Single-center 2-sequence 2-period 2 Treatment Single Dose Crossover Bioequivalence Study Comparing Venglustat Tablet Formulation Test to Hard Capsule Formulation Reference
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 bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions Also to evaluate the safety and tolerability of a single dose tablet and hard capsule of venglustat swallowed whole under fasting conditions in healthy adult participants The maximum duration for participants from screening is up to 47 days
Detailed Description:
Total study duration for participants is up to 47 days including screening up to 20 days 1 day of treatment in period 1 of 8-10 days 1 day of treatment in period 2 of 8 days and 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 |
|---|---|---|---|
| U1111-1239-0220 | REGISTRY | ICTRP | None |