CompletedNCT03971123Updated Jul 8, 2020

Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production

A Phase 1 interventional study of Tricaprilin and Tricaprilin in Alzheimer Disease, sponsored by Cerecin. Completed at 1 site in Australia. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Cerecin · Phase 1, Interventional, and Basic science

From the registry’s dates

Primary completion was Apr 2020, 6 years 6 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Male

Study 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

Conditions studied

Alzheimer Disease

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Alzheimer Disease 3,678

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Cerecin is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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).

Exclusion criteria

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

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 32 participants (actual)

Study arms

Experimental
AC-SD-03 (for Part 1)
Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.
Drug: Tricaprilin
Experimental
AC-LMP-01 (for Part 1)
Tricaprilin LMP formulation, single dose (20g tricaprilin). Administered orally.
Drug: Tricaprilin
Experimental
AC-SD-03P (for Part 1)
Placebo formulation, single dose. Administered orally
Drug: Placebo
Experimental
AC-1202 (for Part 2)
Tricaprilin SD formulation, single dose (20g caprylic triglyceride). Administered orally.
Drug: Tricaprilin
Experimental
AC-SD-03 (for Part 2)
Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.
Drug: Tricaprilin

Interventions

DrugTricaprilin
Tricaprilin formulated as AC-SD-03 50g of AC-SD-03 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1
Also known as: AC-SD-03
DrugTricaprilin
Tricaprilin formulated as AC-LMP-01 50g of AC-LMP-01 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1
Also known as: AC-LMP-01
DrugPlacebo
Matching placebo to AC-SD-03 50g of AC-SD-03P mixed in 240mL dosing liquid at Hour 0 Day 1
Also known as: AC-SD-03P
DrugTricaprilin
Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1
Also known as: AC-1202

What researchers measure

Primary outcomes

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)
Number of subjects with treatment related adverse events as assessed by CTCAE
Time frame: 11 days
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)
AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. AUC (0-t) = Area under the concentration-time curve from 0 to last quantifiable concentration. Summary statistics will be generated for each PK parameter.
Time frame: 1 day
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)
Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.
Time frame: 1 day
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)
Tmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. Tmax = Time to reach maximum observed concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.
Time frame: 1 day

Secondary outcomes

ApoE4 Genotyping (for Part 1 only)
The Apo-E test provides a value represented by the type of the allele (E2, E3,E4).The allelic variant of the Apo-E (APOE4) will be evaluated for effects on tricaprilin induced ketone body production.
Time frame: 1 day

Study locations

1 site

Nucleus Network
Melbourne, Victoria 3004, Australia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03971123
Lead sponsor: Cerecin
Responsible party: Sponsor
First posted: Jun 3, 2019
Start date: Aug 30, 2019
Primary completion: Apr 2, 2020
Completion: May 26, 2020
Last update: Jul 8, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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