A Phase 1 interventional study of Tricaprilin in Alzheimer Disease, sponsored by Cerecin. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by Cerecin · Phase 1, Interventional, and Basic science
This is a Phase I, single center, open label, multiple dose, pharmacokinetic (PK) study recruiting healthy older subjects.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Cerecin is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Unable to refrain from, or anticipates the use of drugs other than allowed products, including prescription and non-prescription medications, beginning 14 days prior to the first dose and throughout the study.
Study drug administered concurrently with a standard meal
Drug: Tricaprilin
Tricaprilin formulated as AC-SD-03 mixed in 300mL water
Safety and tolerability of multiple-dose administrations of tricaprilin formulated as AC-SD-03 administered using a titration scheme in healthy older volunteers
TEAE incidence rate
Time frame: 32 days
Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using AUC(0-t)
AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) Levels. AUC (0-t) = Area under the concentration-time curve from 0 to last quantifiable concentration. Summary statistics will be generated for each PK parameter.
Time frame: 28 days
Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using Cmax
Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) Levels. Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.
Time frame: 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Cerecin