Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
NCT ID: NCT03551769
Last Updated: 2019-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2018-08-05
2018-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Cohort 1, Period 1
Study drug administered concurrently with a standard meal
tricaprilin
Tricaprilin formulated as AC-SD-01
standard meal
standard meal
Cohort 1, Period 2
Study drug administered 30 minutes after a standard meal
tricaprilin
Tricaprilin formulated as AC-SD-01
standard meal
standard meal
Cohort 1, Period 3
Study drug administered 30 minutes after a high-fat meal
tricaprilin
Tricaprilin formulated as AC-SD-01
high-fat meal
high-fat meal
Cohort 1, Period 4
Study drug administered after an overnight fast
tricaprilin
Tricaprilin formulated as AC-SD-01
Cohort 2, Period 1
Study drug administered 30 minutes after a standard meal (Asian)
tricaprilin
Tricaprilin formulated as AC-SD-01
standard meal
standard meal
Cohort 2, Period 2
Study drug administered after an overnight fast (Asian)
tricaprilin
Tricaprilin formulated as AC-SD-01
overnight fast
fasting for at least 9 hours
Interventions
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tricaprilin
Tricaprilin formulated as AC-SD-01
standard meal
standard meal
high-fat meal
high-fat meal
overnight fast
fasting for at least 9 hours
Eligibility Criteria
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Inclusion Criteria
* 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
* Has been on a ketogenic diet as supported by review of a food diary
* Has positive Urine Drug Screen or alcohol results at Screening
18 Years
55 Years
MALE
Yes
Sponsors
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Cerecin
INDUSTRY
Responsible Party
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Locations
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Nucleus Network
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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AC-18-016_FE
Identifier Type: -
Identifier Source: org_study_id
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