Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05628636
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2022-11-09
Brief Title:
AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
A Phase 1 Open-label Study to Evaluate the Tolerability of 21 Days of Treatment With the AC-OLE-01-VA Formulation of Tricaprilin Under Different Dosing Conditions in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2023-10
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 an open-label 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin
Following a screening of up to 28 days eligible participants will be initially randomised to one of 2 arms Arm 1 or Arm 2 Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3
Following a screening of up to 28 days eligible participants will be initially randomised to one of 2 arms Arm 1 or Arm 2 Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3
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