Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-28 @ 7:08 PM
Study NCT ID:
NCT03551769
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2018-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
Sponsor:
Cerecin
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
Status:
COMPLETED
Status Verified Date:
2019-05
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:
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
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?: