NCT03971123

Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production

A Phase 1, Randomised, Single-center, Single-dose, Placebo-controlled, 3-Way Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability of a Lipid Multi-particulate (LMP) Formulation and Spray-dried (SD) Formulations of Tricaprilin (TC) on Ketone Body Production (Part 1). Addendum to Include a 2-way Crossover to Compare the Pharmacokinetics, Safety and Tolerability of Two Spray-dried (SD) Formulations of Tricaprilin (TC) on Ketone Body Production (Part 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cerecin · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Phase 1, Single-center, Open-label Study, Healthy Adult Male Subjects. Part 1:Single-dose, Placebo-controlled, 3-Way Crossover PK Study Part 2: Single dose 2-way comparator PK Study

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Tricaprilin	Tricaprilin formulated as AC-SD-03 50g of AC-SD-03 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1
DRUG	Tricaprilin	Tricaprilin formulated as AC-LMP-01 50g of AC-LMP-01 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1
DRUG	Placebo	Matching placebo to AC-SD-03 50g of AC-SD-03P mixed in 240mL dosing liquid at Hour 0 Day 1
DRUG	Tricaprilin	Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1

Timeline

• Start date: 2019-08-30
• Primary completion: 2020-04-02
• Completion: 2020-05-26
• First posted: 2019-06-03
• Last updated: 2020-07-08

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study