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

Cerecin (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Anticipated Enrollment :
18 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Nov 14, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Days 1-3: 5 g BID 4-6: 10 g BID 7-9: 15 g BID 10-21: 20 g BID

Drug: AC-OLE-01-VA
formulation of tricaprilin

Experimental: Arm 2

Days 1-3: 10 g BID 4-6: 10 g BID 7-9: 10 g BID 10-21: 20 g BID

Drug: AC-OLE-01-VA
formulation of tricaprilin

Experimental: Arm 3

Days 1-3: 15 g TID 4-6: 10 g TID 7-9: 10 g TID 10-21: 15 g TID

Drug: AC-OLE-01-VA
formulation of tricaprilin

Outcome Measures

Primary Outcome Measures

  1. Ratings of discomfort of the adverse events nausea, dyspepsia, abdominal pain, abdominal distension, diarrhoea [21 days]

    Discomfort rating from 0 (no discomfort) to 4 (severe discomfort)

  2. Incidence of adverse events [21 days]

    Adverse event incidence will be tabulated Adverse event incidence will be tabulated Adverse event incidence will be tabulated

Eligibility Criteria


Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 RDC Clinical Newstead Queensland Australia 4006

Sponsors and Collaborators

  • Cerecin


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Cerecin Identifier:
Other Study ID Numbers:
  • AC-22-031
First Posted:
Nov 29, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 15, 2022