NCT02833012

Brief Summary

To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil, AC-1202, AC-1204, and Axona®.

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 healthy

Timeline
Completed

Started Jul 2016

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

July 12, 2016

Last Update Submit

April 10, 2017

Conditions

Healthy

Keywords

Healthy volunteersCaprylic triglyceride oilAC-1202AC-1204Pharmacokineticketone bodyAxona

Outcome Measures

Primary Outcomes (21)

  • total ketones AUC0-t

    The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.

    0-24 hours

  • total ketones AUC0-inf

    The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.

    0-24 hours

  • total ketones AUC%extap

    Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)\*100

    0-24 hours

  • total ketones Cmax

    Maximum observed concentration

    0-24 hours

  • total ketones Kel

    Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations)

    0-24 hours

  • total ketones T 1/2

    Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel

    0-24 hours

  • total ketones Tmax

    Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value

    0-24 hours

  • β hydroxybutyrate AUC0-t

    The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.

    0-24 hours

  • β hydroxybutyrate AUC0-inf

    The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.

    0-24 hours

  • β hydroxybutyrate AUC%extap

    Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)\*100

    0-24 hours

  • β hydroxybutyrate Cmax

    Maximum observed concentration

    0-24 hours

  • β hydroxybutyrate Kel

    Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations)

    0-24 hours

  • β hydroxybutyrate T 1/2

    Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel

    0-24 hours

  • β hydroxybutyrate Tmax

    Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value

    0-24 hours

  • estimate of acetoacetate AUC0-t

    The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.

    0-24 hours

  • estimate of acetoacetate AUC0-inf

    The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.

    0-24 hours

  • estimate of acetoacetate AUC%extap

    Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)\*100

    0-24 hours

  • estimate of acetoacetate Cmax

    Maximum observed concentration

    0-24 hours

  • estimate of acetoacetate Kel

    Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero serum concentrations)

    0-24 hours

  • estimate of acetoacetate T 1/2

    Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel

    0-24 hours

  • estimate of acetoacetate Tmax

    Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value

    0-24 hours

Study Arms (4)

Group 1

EXPERIMENTAL

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Drug: Caprylic Triglyceride OilDrug: AC-1202Drug: AxonaDrug: AC-1204

Group 2

EXPERIMENTAL

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Drug: Caprylic Triglyceride OilDrug: AC-1202Drug: AxonaDrug: AC-1204

Group 3

EXPERIMENTAL

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Drug: Caprylic Triglyceride OilDrug: AC-1202Drug: AxonaDrug: AC-1204

Group 4

EXPERIMENTAL

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Drug: Caprylic Triglyceride OilDrug: AC-1202Drug: AxonaDrug: AC-1204

Interventions

Caprylic Triglyceride OilDRUG

10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1

Group 1Group 2Group 3Group 4
AC-1202DRUG

60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1

Group 1Group 2Group 3Group 4
AxonaDRUG

40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1

Group 1Group 2Group 3Group 4
AC-1204DRUG

40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Group 1Group 2Group 3Group 4

Eligibility Criteria

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

You may qualify if:

  • Healthy, adult, male 18-55 years of age, inclusive, at screening.
  • Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to Day -1 of Period 1 and throughout the study.
  • Body mass index (BMI) ≥ 20.0 and ≤ 30.0 kg/m2 at screening.
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee. At screening, subjects must have alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) \< the upper limit of normal and triglyceride levels must be \< 250 mg/dL.
  • A non-vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to Day -1 of Period 1. A subject who has been vasectomized less than 4 months prior to Day -1 of Period 1 must follow the same restrictions as a non vasectomized male).
  • Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if:

  • Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
  • History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
  • History or presence of alcoholism or drug abuse within the past 2 years prior to Day -1 of Period 1.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, palm or coconut oil, or soy.
  • History or presence of diverticular disease, ulcers, inflammatory bowel disease or recurrent diarrhea or gout.
  • Positive urine drug or alcohol results at screening or check in.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
  • Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
  • Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
  • QTcF interval is \>460 msec or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
  • Estimated creatinine clearance ≤80 mL/min at screening.
  • Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to Day -1 of Period 1 and throughout the study. Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.
  • Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 28 days prior to Day -1 of Period 1 and throughout the study.
  • Is lactose intolerant.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion, Inc

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

tricaprylinAC-1202caprylidene

Study Officials

  • Colleen Hunsaker, D.O.

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

US(1)