Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production
NCT02833012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2017-04-11
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
- 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
Sponsors & Collaborators
-
Celerion
collaborator INDUSTRY -
Cerecin
lead INDUSTRY
Principal Investigators
-
Colleen Hunsaker, D.O. · Celerion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2016-09-30
- Completion
- 2016-12-31
Countries
- United States
Study Locations
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