Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

• Status: Completed
• Trial end date: 2018-08-27
• Target enrollment: 0
• Participant gender: Male

Summary

This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Accera, Inc.; Cerecin

Criteria

Inclusion Criteria:

• Healthy adult male, ages 18 - 55

• Able to consume a regular diet and one high fat meal; no specific dietary requirements

• Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage

Exclusion Criteria:

• Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject

• Has been on a ketogenic diet as supported by review of a food diary

• Has positive Urine Drug Screen or alcohol results at Screening