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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
AC-18-016_FE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total ketones - Area Under the Curve (AUC) AUC 0-last
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Total ketones - AUC 0 - 4
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Total ketones - AUC 0 - 6
Timepoint [3] 0 0
1 day
Primary outcome [4] 0 0
Total ketones - AUC 0-8
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
Total ketones - Maximum Plasma Concentration (Cmax)
Timepoint [5] 0 0
1 day
Primary outcome [6] 0 0
B-hydrodxybutyrate - AUC 0-last
Timepoint [6] 0 0
1 day
Primary outcome [7] 0 0
B-hydroxybutyrate - AUC 0-4
Timepoint [7] 0 0
1 day
Primary outcome [8] 0 0
B-hydroxybutyrate - AUC 0-6
Timepoint [8] 0 0
1 day
Primary outcome [9] 0 0
B-hydroxybutyrate - AUC 0-8
Timepoint [9] 0 0
1 day
Primary outcome [10] 0 0
B-hydroxybutyrate - Cmax
Timepoint [10] 0 0
1 day
Primary outcome [11] 0 0
Acetoacetate - AUC 0-last
Timepoint [11] 0 0
1 day
Primary outcome [12] 0 0
Acetoacetate - AUC 0-4
Timepoint [12] 0 0
1 day
Primary outcome [13] 0 0
Acetoacetate - AUC 0-6
Timepoint [13] 0 0
1 day
Primary outcome [14] 0 0
Acetoacetate - AUC 0-8
Timepoint [14] 0 0
1 day
Primary outcome [15] 0 0
Acetoacetate - Cmax
Timepoint [15] 0 0
1 day
Secondary outcome [1] 0 0
tricaprilin - AUC 0 - last
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
tricaprilin - AUC 0 - 4
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
tricaprilin - AUC 0 - 6
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
tricaprilin - AUC 0 - 8
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
tricaprilin - Time to maximum concentration (Tmax)
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
tricaprilin - Cmax
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
octanoic acid - AUC 0 - last
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
octanoic acid - AUC 0 - 4
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
octanoic acid - AUC 0 - 6
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
octanoic acid - AUC 0 - 8
Timepoint [10] 0 0
1 day
Secondary outcome [11] 0 0
octanoic acid - Tmax
Timepoint [11] 0 0
1 day
Secondary outcome [12] 0 0
octanoic acid - Cmax
Timepoint [12] 0 0
1 day
Secondary outcome [13] 0 0
Computerized Cognitive Battery - Attention - Rapid Visual Information Processing Test
Timepoint [13] 0 0
1 day
Secondary outcome [14] 0 0
Computerized Cognitive Battery - Episodic Memory - Paired Associates Learning Test
Timepoint [14] 0 0
1 day
Secondary outcome [15] 0 0
Computerized Cognitive Battery - Working Memory - Spatial Working Memory Test
Timepoint [15] 0 0
1 day
Secondary outcome [16] 0 0
Computerized Cognitive Battery - Psychomotor Function - Reaction Time Test
Timepoint [16] 0 0
1 day

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
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cerecin
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03551769
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications