Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421714
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-05-13
Brief Title:
A Study of the Safety Tolerability and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase I Single-Center Open-Label Two-Period Single Sequence Two Treatment Drug-Drug Interaction Study of GZSAR402671 Venglustat and Itraconazole in Healthy Male 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:
The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole The maximum duration for participants from screening is between 32 to 62 days
Detailed Description:
Total study duration for participants is up to 62 days including screening up to 28 days 1 day of treatment in period 1 washout of 7 days 13 days of treatment in period 2 and follow up period 10-14 days after last dose
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 |
|---|---|---|---|
| 2014-002550-39 | EUDRACT_NUMBER | None | None |