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AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions | Clinical Trials | Clareo Health

COMPLETEDPHASE1

AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions

A Phase 1, Open-label Study to Evaluate the Tolerability of 21 Days of Treatment With the AC-OLE-01-VA Formulation of Tricaprilin Under Different Dosing Conditions in Healthy Participants

NCT05628636•Cerecin

View on ClinicalTrials.gov

Summary

This is an open-label, 3-arm study to compare tolerability of three different titration and dosing schedules of the AC-OLE-01-VA formulation of tricaprilin. Following a screening of up to 28 days, eligible participants will be initially randomised to one of 2 arms (Arm 1 or Arm 2). Arms 1 and 2 will be completed in advance of Arm 3 with all subsequent participants allocated to Arm 3.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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).

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.
•Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products within 3 months prior to screening.

Locations (1)

RDC Clinical

Newstead, Queensland, Australia

Key Dates

Start Date

November 14, 2022

Primary Completion Date

December 22, 2022

Completion Date

April 3, 2023

Last Updated

October 18, 2023

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

AC-OLE-01-VA

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions

Inclusion Criteria

Exclusion Criteria

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

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