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

July 7, 2020 updated by: Cerecin

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AC-SD-03
Study drug administered concurrently with a standard meal
Tricaprilin formulated as AC-SD-03 mixed in 300mL water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of multiple-dose administrations of tricaprilin formulated as AC-SD-03 administered using a titration scheme in healthy older volunteers
Time Frame: 32 days
TEAE incidence rate
32 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using AUC(0-t)
Time Frame: 28 days
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.
28 days
Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using Cmax
Time Frame: 28 days
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Actual)

March 26, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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