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

NCT ID: NCT03971123

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2020-05-26

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

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AC-SD-03 (for Part 1)

Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.

Group Type: EXPERIMENTAL

Tricaprilin

Intervention Type: DRUG

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

AC-LMP-01 (for Part 1)

Tricaprilin LMP formulation, single dose (20g tricaprilin). Administered orally.

Group Type: EXPERIMENTAL

Tricaprilin

Intervention Type: DRUG

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

AC-SD-03P (for Part 1)

Placebo formulation, single dose. Administered orally

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

AC-1202 (for Part 2)

Tricaprilin SD formulation, single dose (20g caprylic triglyceride). Administered orally.

Group Type: EXPERIMENTAL

Tricaprilin

Intervention Type: DRUG

Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1

AC-SD-03 (for Part 2)

Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.

Group Type: EXPERIMENTAL

Tricaprilin

Intervention Type: DRUG

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

Interventions

Tricaprilin

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

Intervention Type: DRUG

Tricaprilin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Tricaprilin

Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1

Intervention Type: DRUG

Other Intervention Names

AC-SD-03; AC-LMP-01; AC-SD-03P; AC-1202

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cerecin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

AC-19-017

Identifier Type: -

Identifier Source: org_study_id