NCT05408780

A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects

A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cerecin · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	AC-OLE-01-VA	formulation of tricaprilin or matching placebo

Timeline

• Start date: 2022-07-14
• Primary completion: 2022-08-13
• Completion: 2022-10-24
• First posted: 2022-06-07
• Last updated: 2023-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study