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

• Sponsor: Cerecin (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05628636
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 2.6
• Patients Per Site Per Month: 6.9

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
Alzheimer Disease	Drug: AC-OLE-01-VA	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: 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

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Cerecin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerecin
• ClinicalTrials.gov Identifier: NCT05628636
• 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: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Dec 15, 2022