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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: AC-OLE-01-VA

• Registration Number: NCT05628636
• Lead Sponsor: Cerecin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-09
• Study Start: 2022-11-14
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-29
• Primary Completion: 2022-12-22
• Study Completion: 2023-04-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	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
Arm 1	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	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

RDC Clinical; 🇦🇺 Newstead, Queensland, Australia