Alzheimer Disease
Conditions
Brief summary
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
Interventions
DRUGtricaprilin
Tricaprilin formulated as AC-SD-01
OTHERovernight fast
fasting for at least 9 hours
OTHERstandard meal
standard meal
OTHERhigh-fat meal
high-fat meal
Sponsors
Cerecin
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male, ages 18 - 55 * Able to consume a regular diet and one high fat meal; no specific dietary requirements * Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage
Exclusion criteria
* Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject * Has been on a ketogenic diet as supported by review of a food diary * Has positive Urine Drug Screen or alcohol results at Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total ketones | 1 day | Area Under the Curve (AUC) AUC 0-last |
| B-hydrodxybutyrate | 1 day | AUC 0-last |
| B-hydroxybutyrate | 1 day | AUC 0-4 |
| Acetoacetate | 1 day | AUC 0-last |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Computerized Cognitive Battery - Working Memory | 1 day | Spatial Working Memory Test |
| tricaprilin | 1 day | AUC 0 - last |
| Computerized Cognitive Battery - Psychomotor Function | 1 day | Reaction Time Test |
| octanoic acid | 1 day | AUC 0 - last |
| Computerized Cognitive Battery - Attention | 1 day | Rapid Visual Information Processing Test |
| Computerized Cognitive Battery - Episodic Memory | 1 day | Paired Associates Learning Test |
Countries
Australia
Outcome results
None listed