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This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Period 1 | Experimental | Study drug administered concurrently with a standard meal |
|
| Cohort 1, Period 2 | Experimental | Study drug administered 30 minutes after a standard meal |
|
| Cohort 1, Period 3 | Experimental | Study drug administered 30 minutes after a high-fat meal |
|
| Cohort 1, Period 4 | Experimental | Study drug administered after an overnight fast |
|
| Cohort 2, Period 1 | Experimental | Study drug administered 30 minutes after a standard meal (Asian) |
|
| Cohort 2, Period 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tricaprilin | Drug | Tricaprilin formulated as AC-SD-01 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total ketones | Area Under the Curve (AUC) AUC 0-last | 1 day |
| Total ketones | AUC 0 - 4 | 1 day |
| Total ketones | AUC 0 - 6 | 1 day |
| Total ketones | AUC 0-8 | 1 day |
| Total ketones | Maximum Plasma Concentration (Cmax) | 1 day |
| B-hydrodxybutyrate | AUC 0-last | 1 day |
| B-hydroxybutyrate | AUC 0-4 | 1 day |
| B-hydroxybutyrate | AUC 0-6 | 1 day |
| B-hydroxybutyrate | AUC 0-8 | 1 day |
| B-hydroxybutyrate | Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| tricaprilin | AUC 0 - last | 1 day |
| tricaprilin | AUC 0 - 4 | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C003637 | tricaprylin |
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Study drug administered after an overnight fast (Asian)
|
| standard meal | Other | standard meal |
|
| high-fat meal | Other | high-fat meal |
|
| overnight fast | Other | fasting for at least 9 hours |
|
| 1 day |
| Acetoacetate | AUC 0-last | 1 day |
| Acetoacetate | AUC 0-4 | 1 day |
| Acetoacetate | AUC 0-6 | 1 day |
| Acetoacetate | AUC 0-8 | 1 day |
| Acetoacetate | Cmax | 1 day |
| tricaprilin |
AUC 0 - 6 |
| 1 day |
| tricaprilin | AUC 0 - 8 | 1 day |
| tricaprilin | Time to maximum concentration (Tmax) | 1 day |
| tricaprilin | Cmax | 1 day |
| octanoic acid | AUC 0 - last | 1 day |
| octanoic acid | AUC 0 - 4 | 1 day |
| octanoic acid | AUC 0 - 6 | 1 day |
| octanoic acid | AUC 0 - 8 | 1 day |
| octanoic acid | Tmax | 1 day |
| octanoic acid | Cmax | 1 day |
| Computerized Cognitive Battery - Attention | Rapid Visual Information Processing Test | 1 day |
| Computerized Cognitive Battery - Episodic Memory | Paired Associates Learning Test | 1 day |
| Computerized Cognitive Battery - Working Memory | Spatial Working Memory Test | 1 day |
| Computerized Cognitive Battery - Psychomotor Function | Reaction Time Test | 1 day |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |