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

Cerecin

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Tricaprilin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03971123

AC-19-017

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 5 patient groups

AC-SD-03 (for Part 1)

Experimental group

Description:

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

Treatment:

Drug: Tricaprilin

Drug: Tricaprilin

Drug: Tricaprilin

AC-LMP-01 (for Part 1)

Experimental group

Description:

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

Treatment:

Drug: Tricaprilin

Drug: Tricaprilin

Drug: Tricaprilin

AC-SD-03P (for Part 1)

Experimental group

Description:

Placebo formulation, single dose. Administered orally

Treatment:

Drug: Placebo

AC-1202 (for Part 2)

Experimental group

Description:

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

Treatment:

Drug: Tricaprilin

Drug: Tricaprilin

Drug: Tricaprilin

AC-SD-03 (for Part 2)

Experimental group

Description:

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

Treatment:

Drug: Tricaprilin

Drug: Tricaprilin

Drug: Tricaprilin