Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

Cerecin

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: tricaprilin; Other: high-fat meal; Other: standard meal; Other: overnight fast

Study type: Interventional

Funder types: Industry

Identifiers

NCT03551769

AC-18-016_FE

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Cohort 1, Period 1

Experimental group

Description:

Study drug administered concurrently with a standard meal

Treatment:

Other: standard meal

Drug: tricaprilin

Cohort 1, Period 2

Experimental group

Description:

Study drug administered 30 minutes after a standard meal

Treatment:

Other: standard meal

Drug: tricaprilin

Cohort 1, Period 3

Experimental group

Description:

Study drug administered 30 minutes after a high-fat meal

Treatment:

Other: high-fat meal

Drug: tricaprilin

Cohort 1, Period 4

Experimental group

Description:

Study drug administered after an overnight fast

Treatment:

Drug: tricaprilin

Cohort 2, Period 1

Experimental group

Description:

Study drug administered 30 minutes after a standard meal (Asian)

Treatment:

Other: standard meal

Drug: tricaprilin

Cohort 2, Period 2

Experimental group

Description:

Study drug administered after an overnight fast (Asian)

Treatment:

Other: overnight fast

Drug: tricaprilin