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Tricaprilin Liquid Formulation PK Study

NCT ID: NCT05028114

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-07-19

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a three-part study.

Part 1 (Formulation Optimisation): Participants will be assigned to all 4 different formulations of tricaprilin, with randomization to one of 4 sequences with a 2-day washout in between different formulations. There are 2 series in this part.

Part 1 (Food Effect): Participants will be administered to 1 formulation of tricaprilin. There are 2 series in this part.

Part 2 (Placebo Assessment): Participants will be randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods.

Part 3 (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1 (Formulation Optimisation)

Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided 30 minutes after study drug administration. There will be 4 different formulations of the study drug and participants will be randomised to one of 4 sequences. There will be a washout of 2 days between each administration.

Group Type EXPERIMENTAL

AC-1202

Intervention Type DRUG

Tricaprilin formulated as AC-1202

AC-OLE-01

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-02

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-03

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-04

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-05

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-06

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-07

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-08

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-09

Intervention Type DRUG

Tricaprilin Formulation

AC-OLE-010

Intervention Type DRUG

Tricaprilin Formulation

Part 2 (Placebo Assessment)

Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment.

Participants are randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods.

Group Type EXPERIMENTAL

AC-OLE-P

Intervention Type DRUG

Placebo to tricaprilin formulation

Part 3 (Titration Tolerability)

Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment.

Participants will be randomised to either study drug or the matching placebo.

Group Type EXPERIMENTAL

AC-OLE-P

Intervention Type DRUG

Placebo to tricaprilin formulation

Interventions

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AC-1202

Tricaprilin formulated as AC-1202

Intervention Type DRUG

AC-OLE-01

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-02

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-03

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-04

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-05

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-06

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-07

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-08

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-09

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-010

Tricaprilin Formulation

Intervention Type DRUG

AC-OLE-P

Placebo to tricaprilin formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).
* Male and female
* Agrees to comply with study procedures including blood draws, confinement to clinic, meal requirements
* Continuous non-smoker or infrequent smoker (no more than 10 cigarettes per week for at least 3 months prior to Screening)

Exclusion Criteria

* History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement
* Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen \[up to 2 g per day\], hormone replacement therapy and hormonal contraception are permitted).
* Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cerecin

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Cerecin

Locations

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CMAX

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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AC-21-025

Identifier Type: -

Identifier Source: org_study_id

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