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

NCT05628636 — Phase 1, Completed, 18 participants, Cerecin

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05628636
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	18 (Actual)
Sponsor	Cerecin (Industry)
Conditions	Alzheimer Disease
Interventions	AC-OLE-01-VA (Drug)
Dates	start 2022-11-14, primary completion 2022-12-22, completion 2023-04-03, first posted 2022-11-29, last updated 2023-10-18
Locations	1 site in Australia

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Arm 1	Experimental	Drug: AC-OLE-01-VA	Days 1-3: 5 g BID 4-6: 10 g BID 7-9: 15 g BID 10-21: 20 g BID
Arm 2	Experimental	Drug: AC-OLE-01-VA	Days 1-3: 10 g BID 4-6: 10 g BID 7-9: 10 g BID 10-21: 20 g BID
Arm 3	Experimental	Drug: AC-OLE-01-VA	Days 1-3: 15 g TID 4-6: 10 g TID 7-9: 10 g TID 10-21: 15 g TID

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

+Outcome measures

Primary outcomes

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)
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

Sex: All, ages: 18 Years to 55 Years, 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.

+Locations (1)

Facility	City	Country	Status
RDC Clinical	Newstead, Queensland	Australia