AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
NCT ID: NCT05628636
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2022-11-14
2023-04-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1
Days 1-3: 5 g BID 4-6: 10 g BID 7-9: 15 g BID 10-21: 20 g BID
AC-OLE-01-VA
formulation of tricaprilin
Arm 2
Days 1-3: 10 g BID 4-6: 10 g BID 7-9: 10 g BID 10-21: 20 g BID
AC-OLE-01-VA
formulation of tricaprilin
Arm 3
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
formulation of tricaprilin
Interventions
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AC-OLE-01-VA
formulation of tricaprilin
Eligibility Criteria
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Inclusion Criteria
* Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Cerecin
INDUSTRY
Responsible Party
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Locations
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RDC Clinical
Newstead, Queensland, Australia
Countries
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Other Identifiers
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AC-22-031
Identifier Type: -
Identifier Source: org_study_id
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