drugset / Trial / NCT05628636
AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tricaprilin | Other / unclassified | 15 g | — |
| Subject | Tricaprilin | Other / unclassified | 20 g | — |