drugset / Trial / NCT05628636

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

NCT05628636 ↗

Phase 1 Completed 18 enrolled Cerecin
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2022-11-14
Primary completion
2022-12-22
Completion
2023-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tricaprilin Other / unclassified 15 g —
Subject Tricaprilin Other / unclassified 20 g —

Indications