The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
71
CMAX
Adelaide, South Australia, Australia
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time frame: 0 to 8 hours post-dose
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time frame: 0 to 8 hours post-dose
Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Tmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time frame: 0 to 8 hours post-dose
Incidence of treatment emergent adverse events
Adverse event incidence will be tabulated
Time frame: Baseline to end of treatment period
Gastrointestinal side effects of single-dose administration of each of tricaprilin formulations and the placebo formulation (Parts 1, 2) assessed using the Baxter Retching Faces Scale
The Baxter Retching Faces Scale is a pictorial scale rated from 0 to 10, with 6 faces depicting level of nausea/gastrointestinal discomfort.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Gastrointestinal side effects of single-dose administration of each of tricaprilin formulations and the placebo formulation (Parts 1, 2) assessed using the Pain Numerical Rating Scale
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Tricaprilin Formulation
Tricaprilin Formulation
Tricaprilin Formulation
Tricaprilin Formulation
Tricaprilin Formulation
Tricaprilin Formulation
Tricaprilin Formulation
Tricaprilin Formulation
Placebo to tricaprilin formulation
The Pain Numerical Rating Scale 10-point numeric rating scale with participants instructed to rate any abdominal pain from 0 (no pain) to 10 (worst possible pain)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time frame: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time frame: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Tmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time frame: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose