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This is a Phase I, single center, open label, multiple dose, pharmacokinetic (PK) study recruiting healthy older subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-SD-03 | Experimental | Study drug administered concurrently with a standard meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricaprilin | Drug | Tricaprilin formulated as AC-SD-03 mixed in 300mL water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple-dose administrations of tricaprilin formulated as AC-SD-03 administered using a titration scheme in healthy older volunteers | TEAE incidence rate | 32 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using AUC(0-t) | AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) 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. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of alcoholism or substance abuse disorder within the last year.
Positive urine drug screen at Screening or Check-In.
Subject is currently actively using MCTs, ketone esters, or other ketogenic products or is following a ketogenic diet.
Clinically significant abnormal laboratory results at Screening that in the opinion of the PI preclude participating in this study
Participation in another clinical trial within 30 days prior to Check-In.
Subject has a known allergy to the study drug's active or inactive ingredients.
Subject has been following a ketogenic diet (or other diet incompatible with the on-study diet), in the opinion of the investigator.
Unable to refrain from, or anticipates the use of drugs other than allowed products, including prescription and non-prescription medications, beginning 14 days prior to the first dose and throughout the study.
Subject is known HIV, HBV or HCV positive, or has a positive test at Screening.
Any other condition which, in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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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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| Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using Cmax | Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) Levels. Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter. | 28 days |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |