To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil, AC-1202, AC-1204, and Axona®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Celerion, Inc
Tempe, Arizona, United States
total ketones AUC0-t
The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
Time frame: 0-24 hours
total ketones AUC0-inf
The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.
Time frame: 0-24 hours
total ketones AUC%extap
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)\*100
Time frame: 0-24 hours
total ketones Cmax
Maximum observed concentration
Time frame: 0-24 hours
total ketones Kel
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations)
Time frame: 0-24 hours
total ketones T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Time frame: 0-24 hours
total ketones Tmax
Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value
Time frame: 0-24 hours
β hydroxybutyrate AUC0-t
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40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
Time frame: 0-24 hours
β hydroxybutyrate AUC0-inf
The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.
Time frame: 0-24 hours
β hydroxybutyrate AUC%extap
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)\*100
Time frame: 0-24 hours
β hydroxybutyrate Cmax
Maximum observed concentration
Time frame: 0-24 hours
β hydroxybutyrate Kel
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations)
Time frame: 0-24 hours
β hydroxybutyrate T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Time frame: 0-24 hours
β hydroxybutyrate Tmax
Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value
Time frame: 0-24 hours
estimate of acetoacetate AUC0-t
The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
Time frame: 0-24 hours
estimate of acetoacetate AUC0-inf
The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.
Time frame: 0-24 hours
estimate of acetoacetate AUC%extap
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)\*100
Time frame: 0-24 hours
estimate of acetoacetate Cmax
Maximum observed concentration
Time frame: 0-24 hours
estimate of acetoacetate Kel
Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations)
Time frame: 0-24 hours
estimate of acetoacetate T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Time frame: 0-24 hours
estimate of acetoacetate Tmax
Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value
Time frame: 0-24 hours