HealthyPhase 1NCT02833012
Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production
A Phase 1 study testing Caprylic Triglyceride Oil, AC-1202 and Axona in people with Healthy, run by Cerecin at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caprylic Triglyceride Oil, AC-1202 and Axona
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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®.
- Conditions
- Healthy
- Being tested
- Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
- Keywords
- Healthy volunteers, Caprylic triglyceride oil, AC-1202, AC-1204, Pharmacokinetic, ketone body, Axona
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caprylic Triglyceride OilDrug
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
AC-1202Drug
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
AxonaDrug
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
AC-1204Drug
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 Receives: Drug: Caprylic Triglyceride Oil; Drug: AC-1202; Drug: Axona; Drug: AC-1204 |
| Group 2 | Experimental | Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 Receives: Drug: Caprylic Triglyceride Oil; Drug: AC-1202; Drug: Axona; Drug: AC-1204 |
| Group 3 | Experimental | Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 Receives: Drug: Caprylic Triglyceride Oil; Drug: AC-1202; Drug: Axona; Drug: AC-1204 |
| Group 4 | Experimental | Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 Receives: Drug: Caprylic Triglyceride Oil; Drug: AC-1202; Drug: Axona; Drug: AC-1204 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-24 hours
total ketones AUC%extap
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
Measured: 0-24 hours
total ketones Cmax
Maximum observed concentration
Measured: 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)
Measured: 0-24 hours
total ketones T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Measured: 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
Measured: 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.
Measured: 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.
Measured: 0-24 hours
β hydroxybutyrate AUC%extap
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
Measured: 0-24 hours
β hydroxybutyrate Cmax
Maximum observed concentration
Measured: 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)
Measured: 0-24 hours
β hydroxybutyrate T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Measured: 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
Measured: 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.
Measured: 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.
Measured: 0-24 hours
estimate of acetoacetate AUC%extap
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
Measured: 0-24 hours
estimate of acetoacetate Cmax
Maximum observed concentration
Measured: 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)
Measured: 0-24 hours
estimate of acetoacetate T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Measured: 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
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Colleen Hunsaker, D.O., Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833012
- Sponsor's protocol ID
- AC-16-012_BE
- Status last verified
- Apr 2017
- First submitted
- 12 Jul 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02833012
- Acronym / sponsor ID
- AC-16-012_BE
- Conditions
- Healthy
- Keywords
- Healthy volunteers, Caprylic triglyceride oil, AC-1202, AC-1204, Pharmacokinetic, ketone body, Axona
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Caprylic Triglyceride Oil, Drug: AC-1202, Drug: Axona, Drug: AC-1204Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 |
| Group 2 | Experimental | Drug: Caprylic Triglyceride Oil, Drug: AC-1202, Drug: Axona, Drug: AC-1204Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 |
| Group 3 | Experimental | Drug: Caprylic Triglyceride Oil, Drug: AC-1202, Drug: Axona, Drug: AC-1204Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 |
| Group 4 | Experimental | Drug: Caprylic Triglyceride Oil, Drug: AC-1202, Drug: Axona, Drug: AC-1204Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caprylic Triglyceride Oil10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1 | Drug | Group 1, Group 2, Group 3, Group 4 |
| AC-120260 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1 | Drug | Group 1, Group 2, Group 3, Group 4 |
| Axona40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1 | Drug | Group 1, Group 2, Group 3, Group 4 |
| AC-120440 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1 | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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.
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.
total ketones AUC%extap
Time frame: 0-24 hours
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
total ketones Cmax
Time frame: 0-24 hours
Maximum observed concentration
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)
total ketones T 1/2
Time frame: 0-24 hours
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
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
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.
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.
β hydroxybutyrate AUC%extap
Time frame: 0-24 hours
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
β hydroxybutyrate Cmax
Time frame: 0-24 hours
Maximum observed concentration
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)
β hydroxybutyrate T 1/2
Time frame: 0-24 hours
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
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
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.
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.
estimate of acetoacetate AUC%extap
Time frame: 0-24 hours
Percent of AUCo-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
estimate of acetoacetate Cmax
Time frame: 0-24 hours
Maximum observed concentration
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Hunsaker, D.O. principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caprylic Triglyceride Oil, AC-1202 and Axona in people with Healthy, run by Cerecin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total ketones AUC0-t (time frame: 0-24 hours). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.