Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05310058
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2022-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of C6 Ketone Di-ester
Sponsor:
BHB Therapeutics, Ireland LTD
Organization:
Study Overview
Official Title:
A Randomized, Parallel Study to Assess the Pharmacokinetics of C6 Ketone Di-ester in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Randomized, parallel repeat dose pharmacokinetic study of C6 ketone di-ester in a ready to drink beverage matrix.
Detailed Description:
Recruiting 33 healthy adults to participate in a pharmacokinetic (PK) study of C6 ketone di-ester in a ready to drink beverage matrix. Following randomization, subjects will participate in a full day of PK sample collection prior to being sent home with study product for 1 week. After 1 week of daily consumption, subjects will return to the clinic for a second PK study identical to the first. Blood samples will be collected for 8 hours following test product consumption on both PK days.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: