Clinical trial NCT04268953: Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production
Official title: A Phase 1, Single-centre, Multiple-dose, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of the AC-SD-03 Formulation of Tricaprilin in Healthy Older Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase I, single center, open label, multiple dose, pharmacokinetic (PK) study recruiting healthy older subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy, adult, males or females, age 50 years and above, at Screening.
2. Subject must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, Type 2 diabetes, etc) will be permitted to enrol.
3. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
4. Agrees to comply with study procedures including the confinement period of 28 days.
5. Subject is able and willing to consume a prescribed full breakfast, lunch and dinner while confined in the CRU. Subject does not have specific dietary requirements (vegetarian, vegan, lactose-free, low-fat, etc.).
6. Subject is not consuming a ketogenic diet (defined by consumption of \< 50 gm carbohydrates per day).
7. A non vasectomized male subject must agree to use a condom or abstain from sexual intercourse during the study and for 90 days following last dose of AC-SD 03. 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.
8. Female subjects must be either surgically sterile or 2 or more years post-menopause.
9. Has given voluntary, written informed consent to participate in the study.

Exclusion Criteria:

1. History or presence of alcoholism or substance abuse disorder within the last year.
2. Positive urine drug screen at Screening or Check-In.
3. Subject is currently actively using MCTs, ketone esters, or other ketogenic products or is following a ketogenic diet.
4. Clinically significant abnormal laboratory results at Screening that in the opinion of the PI preclude participating in this study
5. Participation in another clinical trial within 30 days prior to Check-In.
6. Subject has a known allergy to the study drug's active or inactive ingredients.
7. Subject has been following a ketogenic diet (or other diet incompatible with the on-study diet), in the opinion of the investigator.
8. Unable to refrain from, or anticipates the use of drugs other than allowed products, including prescription and non-prescription medications, beginning 14 days prior to the first dose and throughout the study.

   1. Allowed medications include anti-hypertensive agents, statins, aspirin in a dose of 100 mg or less per day for prophylaxis.
   2. Paracetamol (acetaminophen), up to 4 g per 24 hour period, or ibuprofen (up to 1200 mg per 24-hour period) may be permitted during the study.
   3. Herbal remedies and vitamin supplements are permitted in usual doses (not hyper supplementation) so long as subject has been on stable amounts for at least 6 weeks.
   4. Agents being taken to improve memory or cognition are not allowed, whether herbal, 'natural' or pharmaceutical.
9. Subject is known HIV, HBV or HCV positive, or has a positive test at Screening.
10. 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 multiple-dose administrations of tricaprilin formulated as AC-SD-03 administered using a titration scheme in healthy older volunteers
timeFrame: 32 days
Secondary outcomes:
measure: Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using AUC(0-t)
timeFrame: 28 days
measure: Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using Cmax
timeFrame: 28 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
References: