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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of AC-1202 and 2 doses of AC-SD-01.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group ABC | Experimental | AC-1202, AC-SD-01 (50g), AC-SD-01 (75g) |
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| Group BCA | Experimental | AC-SD-01 (50g), AC-SD-01 (75g), AC-1202 |
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| Group CAB | Experimental | AC-SD-01 (75g), AC-1202, AC-SD-01 (50g) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-1202 | Drug | 60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-24 hrs |
| 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. | 0-24 hrs |
| total ketones AUC%extap | Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100 | 0-24 hrs |
| total ketones Cmax | Maximum observed concentration | 0-24 hrs |
| 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., there or more non-zero serum concentrations) | 0-24 hrs |
| total ketones T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel | 0-24 hrs |
| total ketones Tmax | Time to reach Cmax. If the value occurs at more than one time points, Tmax is defined as the first time point with this value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Tomek, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C538853 | AC-1202 |
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16 healthy subjects enrolled, each subject will receive 1 dose of each treatment, with a 2 day washout in between.
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| AC-SD-01 (50 g) | Drug | 50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1 |
|
| AC-SD-01 (75 g) | Drug | 75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1 |
|
| 0-24 hrs |
| β hydroxybutyrate 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. | 0-24 hrs |
| β hydroxybutyrate AUC0-inf | The area under the concentration time curve from time 0 extrapolated to infinity. AUC0inf is calculated as the sum of AUC0t plus the ratio of the last measurable serum concentration to the elimination rate constant. | 0-24 hrs |
| β hydroxybutyrate AUC%extap | Percent of AUC0-inf extrapolated, represented as (1 AUC0t/ AUC0inf)* 100 | 0-24 hrs |
| β hydroxybutyrate Cmax | Maximum observed concentration | 0-24 hrs |
| 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 nonzero serum concentrations) | 0-24 hrs |
| β hydroxybutyrate T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel | 0-24 hrs |
| 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 | 0-24 hrs |
| estimate of acetoacetate AUC0-t | Difference between total ketones AUC0-t and total β hydroxybutyrate AUC0-t | 0-24 hrs |
| estimate of acetoacetate AUC0-inf | Difference between total ketones AUC0-inf and total β hydroxybutyrate AUC0-inf | 0-24 hrs |
| estimate of acetoacetate AUC%extap | Difference between total ketones AUC%extap and total β hydroxybutyrate AUC%extap | 0-24 hrs |
| estimate of acetoacetate Cmax | Difference between total ketones Cmax and total β hydroxybutyrate Cmax | 0-24 hrs |
| estimate of acetoacetate Kel | Difference between total ketones Kel and total β hydroxybutyrate Kel | 0-24 hrs |
| estimate of acetoacetate T 1/2 | Difference between total ketones T 1/2 and total β hydroxybutyrate T 1/2 | 0-24 hrs |
| estimate of acetoacetate Tmax | Difference between total ketones Tmax and total β hydroxybutyrate Tmax | 0-24 hrs |