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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-1204 mixed in water, AC-1202 mixed in water and AC-1202 mixed in Ensure®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AC-1204 mixed in water, AC-1202 mixed in water, AC-1202 mixed in Ensure® |
|
| Group 2 | Experimental | AC-1204 mixed in water, AC-1202 mixed in water, AC-1202 mixed in Ensure® |
|
| Group 3 | Experimental | AC-1204 mixed in water, AC-1202 mixed in water, AC-1202 mixed in Ensure® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-1204 mixed in water | Drug | 40 g AC-1204 (shaken in 240 mL of water) at Hour 0 on 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 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. | 0-24 hours |
| total ketones AUC%extap | Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100 | 0-24 hours |
| total ketones Cmax | Maximum observed concentration | 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., there or more non-zero serum concentrations) | 0-24 hours |
| total ketones T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel | 0-24 hours |
| 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 |
|---|---|---|
| Colleen Hunsaker, D.O. | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| AC-1202 mixed in water | Drug | 60 g AC-1202 (shaken in 240 mL of water) at Hour 0 on Day 1 |
|
| AC-1202 mixed in Ensure® | Drug | 60 g AC-1202 (shaken in approximately 8 oz [237 mL of Ensure® Original] at Hour 0 on Day 1) |
|
| 0-24 hours |
| 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 hours |
| 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 hours |
| β hydroxybutyrate AUC%extap | Percent of AUC0-inf extrapolated, represented as (1 AUC0t/ AUC0inf)* 100 | 0-24 hours |
| β hydroxybutyrate Cmax | Maximum observed concentration | 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 nonzero serum concentrations) | 0-24 hours |
| β hydroxybutyrate T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel | 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 | 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. | 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. | 0-24 hours |
| estimate of acetoacetate AUC%extap | Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)* 100 | 0-24 hours |
| estimate of acetoacetate Cmax | Maximum observed concentration | 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-square regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero concentrations) | 0-24 hours |
| estimate of acetoacetate T 1/2 | Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel | 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 | 0-24 hours |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |