Nucleus Network
Melbourne, Victoria, 3004, Australia
Completed
NCT Number: NCT03551769
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Tricaprilin
DrugTricaprilin formulated as AC-SD-01
Standard meal
Otherstandard meal
High-fat Meal
Otherhigh-fat meal
Overnight fast
Otherfasting for at least 9 hours
Primary outcomes
-
Total ketones
Time frame: 1 day
Area Under the Curve (AUC) AUC 0-last
-
Total ketones
Time frame: 1 day
AUC 0 - 4
-
Total ketones
Time frame: 1 day
AUC 0 - 6
-
Total ketones
Time frame: 1 day
AUC 0-8
-
Total ketones
Time frame: 1 day
Maximum Plasma Concentration (Cmax)
-
B-hydrodxybutyrate
Time frame: 1 day
AUC 0-last
-
B-hydroxybutyrate
Time frame: 1 day
AUC 0-4
-
B-hydroxybutyrate
Time frame: 1 day
AUC 0-6
-
B-hydroxybutyrate
Time frame: 1 day
AUC 0-8
-
B-hydroxybutyrate
Time frame: 1 day
Cmax
-
Acetoacetate
Time frame: 1 day
AUC 0-last
-
Acetoacetate
Time frame: 1 day
AUC 0-4
-
Acetoacetate
Time frame: 1 day
AUC 0-6
-
Acetoacetate
Time frame: 1 day
AUC 0-8
-
Acetoacetate
Time frame: 1 day
Cmax
Secondary outcomes
-
tricaprilin
Time frame: 1 day
AUC 0 - last
-
tricaprilin
Time frame: 1 day
AUC 0 - 4
-
tricaprilin
Time frame: 1 day
AUC 0 - 6
-
tricaprilin
Time frame: 1 day
AUC 0 - 8
-
tricaprilin
Time frame: 1 day
Time to maximum concentration (Tmax)
-
tricaprilin
Time frame: 1 day
Cmax
-
octanoic acid
Time frame: 1 day
AUC 0 - last
-
octanoic acid
Time frame: 1 day
AUC 0 - 4
-
octanoic acid
Time frame: 1 day
AUC 0 - 6
-
octanoic acid
Time frame: 1 day
AUC 0 - 8
-
octanoic acid
Time frame: 1 day
Tmax
-
octanoic acid
Time frame: 1 day
Cmax
-
Computerized Cognitive Battery - Attention
Time frame: 1 day
Rapid Visual Information Processing Test
-
Computerized Cognitive Battery - Episodic Memory
Time frame: 1 day
Paired Associates Learning Test
-
Computerized Cognitive Battery - Working Memory
Time frame: 1 day
Spatial Working Memory Test
-
Computerized Cognitive Battery - Psychomotor Function
Time frame: 1 day
Reaction Time Test
Sponsors and collaborators
Lead sponsor
Cerecin
Industry
Registry information
Official study title
A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
Important dates
- Study start
- 2018
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jun 11, 2018
- Registry last updated
- May 29, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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