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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Total ketones
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Total ketones
Timepoint [3] 0 0
1 day
Primary outcome [4] 0 0
Total ketones
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
Total ketones
Timepoint [5] 0 0
1 day
Primary outcome [6] 0 0
B-hydrodxybutyrate
Timepoint [6] 0 0
1 day
Primary outcome [7] 0 0
B-hydroxybutyrate
Timepoint [7] 0 0
1 day
Primary outcome [8] 0 0
B-hydroxybutyrate
Timepoint [8] 0 0
1 day
Primary outcome [9] 0 0
B-hydroxybutyrate
Timepoint [9] 0 0
1 day
Primary outcome [10] 0 0
B-hydroxybutyrate
Timepoint [10] 0 0
1 day
Primary outcome [11] 0 0
Acetoacetate
Timepoint [11] 0 0
1 day
Primary outcome [12] 0 0
Acetoacetate
Timepoint [12] 0 0
1 day
Primary outcome [13] 0 0
Acetoacetate
Timepoint [13] 0 0
1 day
Primary outcome [14] 0 0
Acetoacetate
Timepoint [14] 0 0
1 day
Primary outcome [15] 0 0
Acetoacetate
Timepoint [15] 0 0
1 day
Secondary outcome [1] 0 0
tricaprilin
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
tricaprilin
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
tricaprilin
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
tricaprilin
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
tricaprilin
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
tricaprilin
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
octanoic acid
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
octanoic acid
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
octanoic acid
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
octanoic acid
Timepoint [10] 0 0
1 day
Secondary outcome [11] 0 0
octanoic acid
Timepoint [11] 0 0
1 day
Secondary outcome [12] 0 0
octanoic acid
Timepoint [12] 0 0
1 day
Secondary outcome [13] 0 0
Computerized Cognitive Battery - Attention
Timepoint [13] 0 0
1 day
Secondary outcome [14] 0 0
Computerized Cognitive Battery - Episodic Memory
Timepoint [14] 0 0
1 day
Secondary outcome [15] 0 0
Computerized Cognitive Battery - Working Memory
Timepoint [15] 0 0
1 day
Secondary outcome [16] 0 0
Computerized Cognitive Battery - Psychomotor Function
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
Sex
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
Other
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
5/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/08/2018
Sample size
Target
Accrual to date
Final
20
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03551769