- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02833012
Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production
April 10, 2017 updated by: Cerecin
A Phase 1, Pilot, Single-Dose, 4-Way Crossover Study to Compare the Pharmacokinetics of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production
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®.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Celerion, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Is unable to complete the meal prior to Day -1 of Period 1.
- Subject consumed grapefruit or Seville oranges within 14 days prior to Day -1 of Period 1.
- Donation of blood or significant blood loss within 56 days prior to Day -1 of Period 1.
- Plasma donation within 7 days prior to Day -1 of Period 1.
- Participation in another clinical study within 28 days prior to Day -1 of Period 1. The 28 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day -1 of Period 1 of the current study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
|
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
|
Experimental: Group 2
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
|
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
|
Experimental: Group 3
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
|
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
|
Experimental: Group 4
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
|
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total ketones AUC0-t
Time Frame: 0-24 hours
|
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
Time Frame: 0-24 hours
|
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 Cmax
Time Frame: 0-24 hours
|
Maximum observed concentration
|
0-24 hours
|
total ketones Kel
Time Frame: 0-24 hours
|
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
Time Frame: 0-24 hours
|
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
|
0-24 hours
|
β hydroxybutyrate AUC0-t
Time Frame: 0-24 hours
|
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 Cmax
Time Frame: 0-24 hours
|
Maximum observed concentration
|
0-24 hours
|
β hydroxybutyrate T 1/2
Time Frame: 0-24 hours
|
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
|
0-24 hours
|
β hydroxybutyrate Tmax
Time Frame: 0-24 hours
|
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
Time Frame: 0-24 hours
|
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
Time Frame: 0-24 hours
|
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 Cmax
Time Frame: 0-24 hours
|
Maximum observed concentration
|
0-24 hours
|
estimate of acetoacetate T 1/2
Time Frame: 0-24 hours
|
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
|
0-24 hours
|
estimate of acetoacetate Tmax
Time Frame: 0-24 hours
|
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
|
total ketones AUC%extap
Time Frame: 0-24 hours
|
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
|
0-24 hours
|
total ketones Tmax
Time Frame: 0-24 hours
|
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-inf
Time Frame: 0-24 hours
|
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
Time Frame: 0-24 hours
|
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
|
0-24 hours
|
β hydroxybutyrate Kel
Time Frame: 0-24 hours
|
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 AUC%extap
Time Frame: 0-24 hours
|
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
|
0-24 hours
|
estimate of acetoacetate Kel
Time Frame: 0-24 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 12, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Actual)
April 11, 2017
Last Update Submitted That Met QC Criteria
April 10, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AC-16-012_BE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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