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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
formulation of tricaprilin
RDC Clinical
Newstead, Queensland, Australia
Ratings of discomfort of the adverse events nausea, dyspepsia, abdominal pain, abdominal distension, diarrhoea
Discomfort rating from 0 (no discomfort) to 4 (severe discomfort)
Time frame: 21 days
Incidence of adverse events
Adverse event incidence will be tabulated Adverse event incidence will be tabulated Adverse event incidence will be tabulated
Time frame: 21 days
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