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The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Food Effect Assessment | Experimental | Subjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods. |
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| Part B - Titration Tolerability | Experimental | Subjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch. Participants will be randomised to either study drug or the matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-OLE-01-VA | Drug | formulation of tricaprilin or matching placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A) | AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate) | 0 to 8 hours post-dose |
| Incidence of Treatment Emergent Adverse Events (Part B) | Adverse event incidence will be tabulated | Baseline to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (Part A) | Adverse event incidence will be tabulated [BARF] Scale) | Baseline to 8 days |
| Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Cerecin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami | Miami | Florida | 33126 | United States |
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This is a two-part study.
Part A (Food Effect Assessment): It is a randomized, double-blind (to IMP received), placebo-controlled, four-period, single-dose design. Subjects will be dosed in the fed state or the fasted state depending on the regimen.
Part B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
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AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate) |
| 0 to 8 hours post-dose |
| Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B) | Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate) | 0 to 8 hours post-dose |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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