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Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
tricaprilin
standard meal
high-fat meal
overnight fast
Sponsored by
Cerecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts 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

Sites / Locations

  • Nucleus Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1, Period 1

Cohort 1, Period 2

Cohort 1, Period 3

Cohort 1, Period 4

Cohort 2, Period 1

Cohort 2, Period 2

Arm Description

Study drug administered concurrently with a standard meal

Study drug administered 30 minutes after a standard meal

Study drug administered 30 minutes after a high-fat meal

Study drug administered after an overnight fast

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

Study drug administered after an overnight fast (Asian)

Outcomes

Primary Outcome Measures

Total ketones
Area Under the Curve (AUC) AUC 0-last
Total ketones
AUC 0 - 4
Total ketones
AUC 0 - 6
Total ketones
AUC 0-8
Total ketones
Maximum Plasma Concentration (Cmax)
B-hydrodxybutyrate
AUC 0-last
B-hydroxybutyrate
AUC 0-4
B-hydroxybutyrate
AUC 0-6
B-hydroxybutyrate
AUC 0-8
B-hydroxybutyrate
Cmax
Acetoacetate
AUC 0-last
Acetoacetate
AUC 0-4
Acetoacetate
AUC 0-6
Acetoacetate
AUC 0-8
Acetoacetate
Cmax

Secondary Outcome Measures

tricaprilin
AUC 0 - last
tricaprilin
AUC 0 - 4
tricaprilin
AUC 0 - 6
tricaprilin
AUC 0 - 8
tricaprilin
Time to maximum concentration (Tmax)
tricaprilin
Cmax
octanoic acid
AUC 0 - last
octanoic acid
AUC 0 - 4
octanoic acid
AUC 0 - 6
octanoic acid
AUC 0 - 8
octanoic acid
Tmax
octanoic acid
Cmax
Computerized Cognitive Battery - Attention
Rapid Visual Information Processing Test
Computerized Cognitive Battery - Episodic Memory
Paired Associates Learning Test
Computerized Cognitive Battery - Working Memory
Spatial Working Memory Test
Computerized Cognitive Battery - Psychomotor Function
Reaction Time Test

Full Information

First Posted
May 17, 2018
Last Updated
May 27, 2019
Sponsor
Cerecin
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1. Study Identification

Unique Protocol Identification Number
NCT03551769
Brief Title
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 5, 2018 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1, Period 1
Arm Type
Experimental
Arm Description
Study drug administered concurrently with a standard meal
Arm Title
Cohort 1, Period 2
Arm Type
Experimental
Arm Description
Study drug administered 30 minutes after a standard meal
Arm Title
Cohort 1, Period 3
Arm Type
Experimental
Arm Description
Study drug administered 30 minutes after a high-fat meal
Arm Title
Cohort 1, Period 4
Arm Type
Experimental
Arm Description
Study drug administered after an overnight fast
Arm Title
Cohort 2, Period 1
Arm Type
Experimental
Arm Description
Study drug administered 30 minutes after a standard meal (Asian)
Arm Title
Cohort 2, Period 2
Arm Type
Experimental
Arm Description
Study drug administered after an overnight fast (Asian)
Intervention Type
Drug
Intervention Name(s)
tricaprilin
Intervention Description
Tricaprilin formulated as AC-SD-01
Intervention Type
Other
Intervention Name(s)
standard meal
Intervention Description
standard meal
Intervention Type
Other
Intervention Name(s)
high-fat meal
Intervention Description
high-fat meal
Intervention Type
Other
Intervention Name(s)
overnight fast
Intervention Description
fasting for at least 9 hours
Primary Outcome Measure Information:
Title
Total ketones
Description
Area Under the Curve (AUC) AUC 0-last
Time Frame
1 day
Title
Total ketones
Description
AUC 0 - 4
Time Frame
1 day
Title
Total ketones
Description
AUC 0 - 6
Time Frame
1 day
Title
Total ketones
Description
AUC 0-8
Time Frame
1 day
Title
Total ketones
Description
Maximum Plasma Concentration (Cmax)
Time Frame
1 day
Title
B-hydrodxybutyrate
Description
AUC 0-last
Time Frame
1 day
Title
B-hydroxybutyrate
Description
AUC 0-4
Time Frame
1 day
Title
B-hydroxybutyrate
Description
AUC 0-6
Time Frame
1 day
Title
B-hydroxybutyrate
Description
AUC 0-8
Time Frame
1 day
Title
B-hydroxybutyrate
Description
Cmax
Time Frame
1 day
Title
Acetoacetate
Description
AUC 0-last
Time Frame
1 day
Title
Acetoacetate
Description
AUC 0-4
Time Frame
1 day
Title
Acetoacetate
Description
AUC 0-6
Time Frame
1 day
Title
Acetoacetate
Description
AUC 0-8
Time Frame
1 day
Title
Acetoacetate
Description
Cmax
Time Frame
1 day
Secondary Outcome Measure Information:
Title
tricaprilin
Description
AUC 0 - last
Time Frame
1 day
Title
tricaprilin
Description
AUC 0 - 4
Time Frame
1 day
Title
tricaprilin
Description
AUC 0 - 6
Time Frame
1 day
Title
tricaprilin
Description
AUC 0 - 8
Time Frame
1 day
Title
tricaprilin
Description
Time to maximum concentration (Tmax)
Time Frame
1 day
Title
tricaprilin
Description
Cmax
Time Frame
1 day
Title
octanoic acid
Description
AUC 0 - last
Time Frame
1 day
Title
octanoic acid
Description
AUC 0 - 4
Time Frame
1 day
Title
octanoic acid
Description
AUC 0 - 6
Time Frame
1 day
Title
octanoic acid
Description
AUC 0 - 8
Time Frame
1 day
Title
octanoic acid
Description
Tmax
Time Frame
1 day
Title
octanoic acid
Description
Cmax
Time Frame
1 day
Title
Computerized Cognitive Battery - Attention
Description
Rapid Visual Information Processing Test
Time Frame
1 day
Title
Computerized Cognitive Battery - Episodic Memory
Description
Paired Associates Learning Test
Time Frame
1 day
Title
Computerized Cognitive Battery - Working Memory
Description
Spatial Working Memory Test
Time Frame
1 day
Title
Computerized Cognitive Battery - Psychomotor Function
Description
Reaction Time Test
Time Frame
1 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Nucleus Network
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production

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