NCT02833012

Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production

A Phase 1, Pilot, Single-Dose, 4-Way Crossover Study to Compare the Pharmacokinetics of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cerecin · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil, AC-1202, AC-1204, and Axona®.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Caprylic Triglyceride Oil	10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
DRUG	AC-1202	60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
DRUG	Axona	40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
DRUG	AC-1204	40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-09-01
• Completion: 2016-12-01
• First posted: 2016-07-14
• Last updated: 2017-04-11

Locations

1 site across 1 country: United States