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Phase 1, Single-center, Open-label Study, Healthy Adult Male Subjects.
Part 1:Single-dose, Placebo-controlled, 3-Way Crossover PK Study
Part 2: Single dose 2-way comparator PK Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-SD-03 (for Part 1) | Experimental | Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally. |
|
| AC-LMP-01 (for Part 1) | Experimental | Tricaprilin LMP formulation, single dose (20g tricaprilin). Administered orally. |
|
| AC-SD-03P (for Part 1) | Experimental | Placebo formulation, single dose. Administered orally |
|
| AC-1202 (for Part 2) | Experimental | Tricaprilin SD formulation, single dose (20g caprylic triglyceride). Administered orally. |
|
| AC-SD-03 (for Part 2) | Experimental | Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricaprilin | Drug | Tricaprilin formulated as AC-SD-03 50g of AC-SD-03 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single-dose administration of each of tricaprilin formulations and the placebo formulation, in healthy, male volunteers (for Part 1 and 2) | Number of subjects with treatment related adverse events as assessed by CTCAE | 11 days |
| Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using AUC(0-t) (for Part 1 and 2) | AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid 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. | 1 day |
| Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using Cmax (for Part 1 and 2) | Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter. | 1 day |
| Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using Tmax (for Part 1 and 2) | Tmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. Tmax = Time to reach maximum observed concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| ApoE4 Genotyping (for Part 1 only) | The Apo-E test provides a value represented by the type of the allele (E2, E3,E4).The allelic variant of the Apo-E (APOE4) will be evaluated for effects on tricaprilin induced ketone body production. | 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 |
| C538853 | AC-1202 |
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|
| Tricaprilin | Drug | Tricaprilin formulated as AC-LMP-01 50g of AC-LMP-01 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1 |
|
|
| Placebo | Drug | Matching placebo to AC-SD-03 50g of AC-SD-03P mixed in 240mL dosing liquid at Hour 0 Day 1 |
|
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| Tricaprilin | Drug | Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1 |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |