Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05028114
Status:
TERMINATED
Last Update Posted:
2023-10-17
First Post:
2021-08-19
Brief Title:
Tricaprilin Liquid Formulation PK Study
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
A Phase 1 Three-part Part-randomised Study to Evaluate the Pharmacokinetics Safety and Tolerability of Different Formulations of Tricaprilin to Include Single-dose Food Effect and Titration Tolerability in Healthy Participants
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Part 1 was completed Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty
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 evaluate the pharmacokinetics safety and tolerability of new liquid formulations of tricaprilin with the aim of finding a suitable formulation to advance in development This is a three-part part-randomised study that include single-dose food effect and titration tolerability in up to 80 healthy participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None