NCT05628636

AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions

A Phase 1, Open-label Study to Evaluate the Tolerability of 21 Days of Treatment With the AC-OLE-01-VA Formulation of Tricaprilin Under Different Dosing Conditions in Healthy Participants

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

Summary

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.

Conditions

• Alzheimer Disease

Interventions

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

Timeline

• Start date: 2022-11-14
• Primary completion: 2022-12-22
• Completion: 2023-04-03
• First posted: 2022-11-29
• Last updated: 2023-10-18

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study