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

NCT02747602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-10-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Cerecin

    lead INDUSTRY

Principal Investigators

  • Geri Poss, MD · Celerion

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-05-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02747602 on ClinicalTrials.gov