NCT03551769

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

11 days

First QC Date

May 17, 2018

Last Update Submit

May 27, 2019

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (15)

  • Total ketones

    Area Under the Curve (AUC) AUC 0-last

    1 day

  • Total ketones

    AUC 0 - 4

    1 day

  • Total ketones

    AUC 0 - 6

    1 day

  • Total ketones

    AUC 0-8

    1 day

  • Total ketones

    Maximum Plasma Concentration (Cmax)

    1 day

  • B-hydrodxybutyrate

    AUC 0-last

    1 day

  • B-hydroxybutyrate

    AUC 0-4

    1 day

  • B-hydroxybutyrate

    AUC 0-6

    1 day

  • B-hydroxybutyrate

    AUC 0-8

    1 day

  • B-hydroxybutyrate

    Cmax

    1 day

  • Acetoacetate

    AUC 0-last

    1 day

  • Acetoacetate

    AUC 0-4

    1 day

  • Acetoacetate

    AUC 0-6

    1 day

  • Acetoacetate

    AUC 0-8

    1 day

  • Acetoacetate

    Cmax

    1 day

Secondary Outcomes (16)

  • tricaprilin

    1 day

  • tricaprilin

    1 day

  • tricaprilin

    1 day

  • tricaprilin

    1 day

  • tricaprilin

    1 day

  • +11 more secondary outcomes

Study Arms (6)

Cohort 1, Period 1

EXPERIMENTAL

Study drug administered concurrently with a standard meal

Drug: tricaprilinOther: standard meal

Cohort 1, Period 2

EXPERIMENTAL

Study drug administered 30 minutes after a standard meal

Drug: tricaprilinOther: standard meal

Cohort 1, Period 3

EXPERIMENTAL

Study drug administered 30 minutes after a high-fat meal

Drug: tricaprilinOther: high-fat meal

Cohort 1, Period 4

EXPERIMENTAL

Study drug administered after an overnight fast

Drug: tricaprilin

Cohort 2, Period 1

EXPERIMENTAL

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

Drug: tricaprilinOther: standard meal

Cohort 2, Period 2

EXPERIMENTAL

Study drug administered after an overnight fast (Asian)

Drug: tricaprilinOther: overnight fast

Interventions

tricaprilinDRUG

Tricaprilin formulated as AC-SD-01

Cohort 1, Period 1Cohort 1, Period 2Cohort 1, Period 3Cohort 1, Period 4Cohort 2, Period 1Cohort 2, Period 2
standard mealOTHER

standard meal

Cohort 1, Period 1Cohort 1, Period 2Cohort 2, Period 1
high-fat mealOTHER

high-fat meal

Cohort 1, Period 3
overnight fastOTHER

fasting for at least 9 hours

Cohort 2, Period 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tricaprylin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 11, 2018

Study Start

August 5, 2018

Primary Completion

August 16, 2018

Study Completion

August 27, 2018

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)