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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03551769
Registration number
NCT03551769
Ethics application status
Date submitted
17/05/2018
Date registered
11/06/2018
Date last updated
29/05/2019
Titles & IDs
Public title
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
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Scientific title
A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
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Secondary ID [1]
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AC-18-016_FE
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tricaprilin
Other interventions - standard meal
Other interventions - high-fat meal
Other interventions - overnight fast
Experimental: Cohort 1, Period 1 - Study drug administered concurrently with a standard meal
Experimental: Cohort 1, Period 2 - Study drug administered 30 minutes after a standard meal
Experimental: Cohort 1, Period 3 - Study drug administered 30 minutes after a high-fat meal
Experimental: Cohort 1, Period 4 - Study drug administered after an overnight fast
Experimental: Cohort 2, Period 1 - Study drug administered 30 minutes after a standard meal (Asian)
Experimental: Cohort 2, Period 2 - Study drug administered after an overnight fast (Asian)
Treatment: Drugs: tricaprilin
Tricaprilin formulated as AC-SD-01
Other interventions: standard meal
standard meal
Other interventions: high-fat meal
high-fat meal
Other interventions: overnight fast
fasting for at least 9 hours
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Total ketones
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Assessment method [1]
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Area Under the Curve (AUC) AUC 0-last
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Timepoint [1]
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1 day
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Primary outcome [2]
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Total ketones
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Assessment method [2]
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AUC 0 - 4
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Timepoint [2]
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1 day
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Primary outcome [3]
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Total ketones
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Assessment method [3]
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AUC 0 - 6
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Timepoint [3]
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1 day
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Primary outcome [4]
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Total ketones
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Assessment method [4]
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AUC 0-8
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Timepoint [4]
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1 day
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Primary outcome [5]
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Total ketones
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Assessment method [5]
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Maximum Plasma Concentration (Cmax)
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Timepoint [5]
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1 day
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Primary outcome [6]
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B-hydrodxybutyrate
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Assessment method [6]
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AUC 0-last
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Timepoint [6]
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1 day
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Primary outcome [7]
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B-hydroxybutyrate
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Assessment method [7]
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AUC 0-4
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Timepoint [7]
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1 day
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Primary outcome [8]
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B-hydroxybutyrate
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Assessment method [8]
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AUC 0-6
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Timepoint [8]
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1 day
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Primary outcome [9]
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B-hydroxybutyrate
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Assessment method [9]
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AUC 0-8
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Timepoint [9]
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1 day
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Primary outcome [10]
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B-hydroxybutyrate
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Assessment method [10]
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Cmax
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Timepoint [10]
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1 day
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Primary outcome [11]
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Acetoacetate
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Assessment method [11]
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AUC 0-last
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Timepoint [11]
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1 day
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Primary outcome [12]
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Acetoacetate
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Assessment method [12]
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AUC 0-4
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Timepoint [12]
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1 day
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Primary outcome [13]
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Acetoacetate
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Assessment method [13]
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AUC 0-6
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Timepoint [13]
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1 day
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Primary outcome [14]
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Acetoacetate
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Assessment method [14]
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AUC 0-8
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Timepoint [14]
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1 day
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Primary outcome [15]
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Acetoacetate
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Assessment method [15]
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Cmax
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Timepoint [15]
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1 day
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Secondary outcome [1]
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tricaprilin
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Assessment method [1]
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AUC 0 - last
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Timepoint [1]
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1 day
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Secondary outcome [2]
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tricaprilin
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Assessment method [2]
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AUC 0 - 4
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Timepoint [2]
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1 day
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Secondary outcome [3]
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tricaprilin
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Assessment method [3]
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AUC 0 - 6
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Timepoint [3]
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1 day
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Secondary outcome [4]
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tricaprilin
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Assessment method [4]
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AUC 0 - 8
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Timepoint [4]
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1 day
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Secondary outcome [5]
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tricaprilin
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Assessment method [5]
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Time to maximum concentration (Tmax)
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Timepoint [5]
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1 day
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Secondary outcome [6]
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tricaprilin
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Assessment method [6]
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Cmax
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Timepoint [6]
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1 day
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Secondary outcome [7]
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octanoic acid
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Assessment method [7]
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AUC 0 - last
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Timepoint [7]
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1 day
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Secondary outcome [8]
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octanoic acid
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Assessment method [8]
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AUC 0 - 4
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Timepoint [8]
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1 day
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Secondary outcome [9]
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octanoic acid
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Assessment method [9]
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AUC 0 - 6
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Timepoint [9]
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1 day
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Secondary outcome [10]
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octanoic acid
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Assessment method [10]
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AUC 0 - 8
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Timepoint [10]
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1 day
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Secondary outcome [11]
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octanoic acid
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Assessment method [11]
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Tmax
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Timepoint [11]
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1 day
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Secondary outcome [12]
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octanoic acid
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Assessment method [12]
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Cmax
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Timepoint [12]
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1 day
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Secondary outcome [13]
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Computerized Cognitive Battery - Attention
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Assessment method [13]
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Rapid Visual Information Processing Test
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Timepoint [13]
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1 day
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Secondary outcome [14]
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Computerized Cognitive Battery - Episodic Memory
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Assessment method [14]
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Paired Associates Learning Test
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Timepoint [14]
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1 day
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Secondary outcome [15]
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Computerized Cognitive Battery - Working Memory
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Assessment method [15]
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Spatial Working Memory Test
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Timepoint [15]
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1 day
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Secondary outcome [16]
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Computerized Cognitive Battery - Psychomotor Function
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Assessment method [16]
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Reaction Time Test
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Timepoint [16]
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1 day
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Basic Science
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/08/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/08/2018
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cerecin
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase I, single center, open label, fixed-order, crossover, food-effect,
pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03551769
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03551769
Download to PDF