AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 alzheimer-disease
Started Nov 2022
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2022
CompletedStudy Start
First participant enrolled
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2023
CompletedOctober 18, 2023
October 1, 2023
1 month
November 9, 2022
October 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Incidence of adverse events
Adverse event incidence will be tabulated Adverse event incidence will be tabulated Adverse event incidence will be tabulated
21 days
Study Arms (3)
Arm 1
EXPERIMENTALDays 1-3: 5 g BID 4-6: 10 g BID 7-9: 15 g BID 10-21: 20 g BID
Arm 2
EXPERIMENTALDays 1-3: 10 g BID 4-6: 10 g BID 7-9: 10 g BID 10-21: 20 g BID
Arm 3
EXPERIMENTALDays 1-3: 15 g TID 4-6: 10 g TID 7-9: 10 g TID 10-21: 15 g TID
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cerecinlead
Study Sites (1)
RDC Clinical
Newstead, Queensland, 4006, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2022
First Posted
November 29, 2022
Study Start
November 14, 2022
Primary Completion
December 22, 2022
Study Completion
April 3, 2023
Last Updated
October 18, 2023
Record last verified: 2023-10