NCT05028114

Tricaprilin Liquid Formulation PK Study

A Phase 1, Three-part, Part-randomised, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Different Formulations of Tricaprilin, to Include Single-dose, Food Effect, and Titration Tolerability, in Healthy Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Cerecin · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	AC-1202	Tricaprilin formulated as AC-1202
DRUG	AC-OLE-01	Tricaprilin Formulation
DRUG	AC-OLE-02	Tricaprilin Formulation
DRUG	AC-OLE-03	Tricaprilin Formulation
DRUG	AC-OLE-04	Tricaprilin Formulation
DRUG	AC-OLE-05	Tricaprilin Formulation
DRUG	AC-OLE-06	Tricaprilin Formulation
DRUG	AC-OLE-07	Tricaprilin Formulation
DRUG	AC-OLE-08	Tricaprilin Formulation
DRUG	AC-OLE-09	Tricaprilin Formulation
DRUG	AC-OLE-010	Tricaprilin Formulation
DRUG	AC-OLE-P	Placebo to tricaprilin formulation

Timeline

• Start date: 2021-08-31
• Primary completion: 2022-03-18
• Completion: 2022-07-19
• First posted: 2021-08-31
• Last updated: 2023-10-17

Locations

1 site across 1 country: Australia