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CompletedNCT04268953Updated Jul 8, 2020

Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production

A Phase 1 interventional study of Tricaprilin in Alzheimer Disease, sponsored by Cerecin. Completed at 1 site in United States. Open to participants aged 50 Years and older, 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 Mar 2020, 6 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Alzheimer Disease

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03

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 12 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

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.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    AC-SD-03

    Study drug administered concurrently with a standard meal

    Drug: Tricaprilin

Interventions

  • DrugTricaprilin

    Tricaprilin formulated as AC-SD-03 mixed in 300mL water

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of multiple-dose administrations of tricaprilin formulated as AC-SD-03 administered using a titration scheme in healthy older volunteers

    TEAE incidence rate

    Time frame: 32 days

Secondary outcomes

  1. Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using AUC(0-t)

    AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) 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: 28 days

  2. Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using Cmax

    Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) Levels. Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.

    Time frame: 28 days

07

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 ↗
10

Registry details

Key details

Study ID
NCT04268953
Lead sponsor
Cerecin
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
Feb 27, 2020
Primary completion
Mar 26, 2020
Completion
May 1, 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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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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