Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
Phase 1
Completed
- Conditions
- Alzheimer Disease
- Interventions
- Registration Number
- NCT03551769
- Lead Sponsor
- Cerecin
- Brief Summary
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1, Period 1 standard meal Study drug administered concurrently with a standard meal Cohort 1, Period 2 standard meal Study drug administered 30 minutes after a standard meal Cohort 2, Period 2 overnight fast Study drug administered after an overnight fast (Asian) Cohort 1, Period 3 high-fat meal Study drug administered 30 minutes after a high-fat meal Cohort 2, Period 1 standard meal Study drug administered 30 minutes after a standard meal (Asian) Cohort 1, Period 2 tricaprilin Study drug administered 30 minutes after a standard meal Cohort 1, Period 3 tricaprilin Study drug administered 30 minutes after a high-fat meal Cohort 1, Period 1 tricaprilin Study drug administered concurrently with a standard meal Cohort 1, Period 4 tricaprilin Study drug administered after an overnight fast Cohort 2, Period 1 tricaprilin Study drug administered 30 minutes after a standard meal (Asian) Cohort 2, Period 2 tricaprilin Study drug administered after an overnight fast (Asian)
- Primary Outcome Measures
Name Time Method B-hydrodxybutyrate 1 day AUC 0-last
Total ketones 1 day Maximum Plasma Concentration (Cmax)
B-hydroxybutyrate 1 day Cmax
Acetoacetate 1 day Cmax
- Secondary Outcome Measures
Name Time Method octanoic acid 1 day Cmax
Computerized Cognitive Battery - Psychomotor Function 1 day Reaction Time Test
Computerized Cognitive Battery - Attention 1 day Rapid Visual Information Processing Test
Computerized Cognitive Battery - Episodic Memory 1 day Paired Associates Learning Test
tricaprilin 1 day Cmax
Computerized Cognitive Battery - Working Memory 1 day Spatial Working Memory Test
Trial Locations
- Locations (1)
Nucleus Network
🇦🇺Melbourne, Victoria, Australia