NCT02747602

Evaluation of PK of AC1204 v Caprylic Triglyceride Oil Incl Food Effect on Ketone Body Production

A Phase 1, Pilot, Single-Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetic of AC-1204 Versus Caprylic Triglyceride Oil Including the Effect of Food on Ketone Body Production

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cerecin · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard breakfast. To evaluate the effect of a high fat diet on serum ketone body levels after administration of CT oil with a high fat breakfast versus a standard breakfast.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AC-1204	40 g (120 mL) AC-1204 administered 30 minutes after the start of a standard breakfast.
DRUG	caprylic triglyceride oil (standard breakfast)	20 g CT oil (21 mL) administered 30 minutes after the start of a standard breakfast.
DRUG	caprylic triglyceride oil (high fat breakfast)	20 g CT oil (21 mL) administered 30 minutes after the start of a high fat breakfast.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-10-01
• First posted: 2016-04-22
• Last updated: 2016-10-28

Locations

1 site across 1 country: United States