Clinical trial NCT03971123: Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: 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)
timeFrame: 11 days
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
measure: 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)
timeFrame: 1 day
Secondary outcomes:
measure: ApoE4 Genotyping (for Part 1 only)
timeFrame: 1 day
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
References: