Ignite Creation Date:
2024-05-06 @ 1:15 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03971123
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2019-05-27
Brief Title:
Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
A Phase 1 Randomised Single-center Single-dose Placebo-controlled 3-Way Crossover Study to Compare the Pharmacokinetics Safety and Tolerability of a Lipid Multi-particulate LMP Formulation and Spray-dried SD Formulations of Tricaprilin TC on Ketone Body Production Part 1 Addendum to Include a 2-way Crossover to Compare the Pharmacokinetics Safety and Tolerability of Two Spray-dried SD Formulations of Tricaprilin TC on Ketone Body Production Part 2
Status:
COMPLETED
Status Verified Date:
2020-07
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:
Phase 1 Single-center Open-label Study Healthy Adult Male Subjects
Part 1Single-dose Placebo-controlled 3-Way Crossover PK Study
Part 2 Single dose 2-way comparator PK Study
Part 1Single-dose Placebo-controlled 3-Way Crossover PK Study
Part 2 Single dose 2-way comparator PK Study
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