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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/NCT03971123




Registration number
NCT03971123
Ethics application status
Date submitted
27/05/2019
Date registered
3/06/2019
Date last updated
8/07/2020

Titles & IDs
Public title
Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production
Scientific title
A Phase 1, Randomised, Single-center, Single-dose, Placebo-controlled, 3-Way Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability of a Lipid Multi-particulate (LMP) Formulation and Spray-dried (SD) Formulations of Tricaprilin (TC) on Ketone Body Production (Part 1). Addendum to Include a 2-way Crossover to Compare the Pharmacokinetics, Safety and Tolerability of Two Spray-dried (SD) Formulations of Tricaprilin (TC) on Ketone Body Production (Part 2)
Secondary ID [1] 0 0
AC-19-017
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
Treatment: Drugs - Tricaprilin
Treatment: Drugs - Placebo
Treatment: Drugs - Tricaprilin

Experimental: AC-SD-03 (for Part 1) - Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.

Experimental: AC-LMP-01 (for Part 1) - Tricaprilin LMP formulation, single dose (20g tricaprilin). Administered orally.

Experimental: AC-SD-03P (for Part 1) - Placebo formulation, single dose. Administered orally

Experimental: AC-1202 (for Part 2) - Tricaprilin SD formulation, single dose (20g caprylic triglyceride). Administered orally.

Experimental: AC-SD-03 (for Part 2) - Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.


Treatment: Drugs: Tricaprilin
Tricaprilin formulated as AC-SD-03 50g of AC-SD-03 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1

Treatment: Drugs: Tricaprilin
Tricaprilin formulated as AC-LMP-01 50g of AC-LMP-01 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1

Treatment: Drugs: Placebo
Matching placebo to AC-SD-03 50g of AC-SD-03P mixed in 240mL dosing liquid at Hour 0 Day 1

Treatment: Drugs: Tricaprilin
Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of single-dose administration of each of tricaprilin formulations and the placebo formulation, in healthy, male volunteers (for Part 1 and 2)
Timepoint [1] 0 0
11 days
Primary outcome [2] 0 0
Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using AUC(0-t) (for Part 1 and 2)
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using Cmax (for Part 1 and 2)
Timepoint [3] 0 0
1 day
Primary outcome [4] 0 0
Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using Tmax (for Part 1 and 2)
Timepoint [4] 0 0
1 day
Secondary outcome [1] 0 0
ApoE4 Genotyping (for Part 1 only)
Timepoint [1] 0 0
1 day

Eligibility
Key inclusion criteria
- Healthy, adult, male 18 - 50 years of age, inclusive, at Screening.

- Body mass index (BMI) = 18.0 and = 32.0 kg/m2 at Screening.

- Agrees to comply with study procedures.

- Continuous non smoker who has not used nicotine containing products or smoking no more
than 10 cigarettes per week for at least 3 months prior to Screening and will not use
them throughout the study.

- A non-vasectomized subject must agree to use a condom or abstain from sexual
intercourse during the study. No restrictions are required for a vasectomized male
provided his vasectomy has been performed 4 months or more prior to Screening. A
subject who has been vasectomized less than 4 months prior to Screening must follow
the same restrictions as a non-vasectomized male.

- Subject is able and willing to consume a prescribed full breakfast on at least 3
occasions. Subject does not have specific dietary requirements (vegetarian, vegan,
lactose-free, low-fat, etc.).

- Subject is not consuming a ketogenic diet (defined by consumption of < 50 gm
carbohydrates per day).

- Has given voluntary, written informed consent to participate in the study.

- For Cohort 1, the Chinese subjects are restricted to being of Chinese heritage
(irrespective of country of residence) and defined as all 4 grandparents of the
subject must be Chinese (for Part 1 only).
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History or presence of alcoholism or substance abuse disorder within the last year.

- Positive urine drug screen at Screening or Check-in.

- Subject is currently actively using MCTs, ketone esters, or other ketogenic products
or is following a ketogenic diet.

- Clinically significant abnormal laboratory results at Screening.

- Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to dosing, or concomitant participation in an investigational
study involving no drug or device administration.

- Subject has a known allergy to the study drug's active or inactive ingredients.

- Subject has been following a ketogenic diet (or other diet incompatible with the
on-study diet), in the opinion of the investigator.

- Unable to refrain from, or anticipates the use of, any drug including prescription and
non-prescription medications, herbal remedies or vitamin supplements beginning 14 days
prior to the first dose and throughout the study, unless deemed acceptable by the PI.
Paracetamol (up to 4g per 24-hour period) or ibuprofen (up to 1,200 mg per 24-hour
period) may be permitted during the study.

- Has had alcohol 48 hours prior to Day -1 of Period 1.

- Any other condition which, in the investigator's opinion may adversely affect the
subject's ability to complete the study or its measures or which may pose significant
risk to the subject.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled 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
30/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/05/2020
Sample size
Target
Accrual to date
Final
32
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
Phase 1, Single-center, Open-label Study, Healthy Adult Male Subjects.

Part 1:Single-dose, Placebo-controlled, 3-Way Crossover PK Study

Part 2: Single dose 2-way comparator PK Study
Trial website
https://clinicaltrials.gov/ct2/show/NCT03971123
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/ct2/show/NCT03971123