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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628636
• Other study ID #: AC-22-031
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2022
• Est. completion date: April 3, 2023

Study information

• Verified date: October 2023
• Source: Cerecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 3, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
Australia	RDC Clinical	Newstead	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratings of discomfort of the adverse events nausea, dyspepsia, abdominal pain, abdominal distension, diarrhoea	Discomfort rating from 0 (no discomfort) to 4 (severe discomfort)	21 days
Primary	Incidence of adverse events	Adverse event incidence will be tabulated Adverse event incidence will be tabulated Adverse event incidence will be tabulated	21 days