HealthyPhase 1NCT02747602
Evaluation of PK of AC1204 v Caprylic Triglyceride Oil Incl Food Effect on Ketone Body Production
A Phase 1 study testing AC-1204, caprylic triglyceride oil (standard breakfast) and caprylic triglyceride oil (high fat breakfast) in people with Healthy, run by Cerecin at 1 site in United States.
Trial summary
To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard breakfast. 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?
- AC-1204, caprylic triglyceride oil (standard breakfast) and caprylic triglyceride oil (high fat breakfast)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 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 the first dose 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 triglycerides levels < 250 mg/dL.
- A non-vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to first dose/dosing of study drug. A subject who has been vasectomized less than 4 months prior to study first dose/dosing must follow the same restrictions as a non-vasectomized male).
- Subjects must agree not to donate sperm from the first dose/dosing until 90 days after dosing.
- 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 the first dose/dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, coconut oil, or soy.
- History or presence of diverticular disease, ulcers, inflammatory bowel disease or recurrent diarrhea or gout.
Show all 19Show 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.
- QTc interval is >460 msec (males) 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 the first dose and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and medications for the treatment of adverse events 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 the first dose and throughout the study.
- Is lactose intolerant.
- Is unable to complete the critical meal (i.e., breakfast prior to dosing).
- Donation of blood or significant blood loss within 56 days prior to the first dose.
- Plasma donation within 7 days prior to the first dose.
- Participation in another clinical study within 28 days prior to the first dose. 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, 3-Way Crossover Study to Evaluate the Pharmacokinetic of AC-1204 Versus Caprylic Triglyceride Oil Including the Effect of Food on Ketone Body Production
To compare serum ketone body (i.e., total ketones and β-hydroxybutyrate) levels after administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard breakfast.
To evaluate the effect of a high fat diet on serum ketone body levels after administration of CT oil with a high fat breakfast versus a standard breakfast.
- Conditions
- Healthy
- Being tested
- AC-1204, caprylic triglyceride oil (standard breakfast), caprylic triglyceride oil (high fat breakfast)
- Keywords
- Healthy volunteers, Caprylic triglyceride oil, AC-1204, Pharmacokinetic, Ketone body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-1204Drug
40 g (120 mL) AC-1204 administered 30 minutes after the start of a standard breakfast.
caprylic triglyceride oil (standard breakfast)Drug
20 g CT oil (21 mL) administered 30 minutes after the start of a standard breakfast.
caprylic triglyceride oil (high fat breakfast)Drug
20 g CT oil (21 mL) administered 30 minutes after the start of a high fat breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Group ABC | Experimental | AC-1204, caprylic triglyceride oil standard breakfast, caprylic triglyceride high fat breakfast Receives: Drug: AC-1204; Drug: caprylic triglyceride oil (standard breakfast); Drug: caprylic triglyceride oil (high fat breakfast) |
| Group BCA | Experimental | caprylic triglyceride oil standard breakfast, caprylic triglyceride high fat breakfast, AC-1204 Receives: Drug: AC-1204; Drug: caprylic triglyceride oil (standard breakfast); Drug: caprylic triglyceride oil (high fat breakfast) |
| Group CAB | Experimental | caprylic triglyceride high fat breakfast, AC-1204, caprylic triglyceride oil standard breakfast Receives: Drug: AC-1204; Drug: caprylic triglyceride oil (standard breakfast); Drug: caprylic triglyceride oil (high fat breakfast) |
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 maximum 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 Tmax
Time to reach Cmax. If the maximum 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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionOct 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Geri Poss, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747602
- Sponsor's protocol ID
- AC-16-011_BE
- Status last verified
- Oct 2016
- First submitted
- 15 Apr 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Pilot, Single-Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetic of AC-1204 Versus Caprylic Triglyceride Oil Including the Effect of Food on Ketone Body Production
- ClinicalTrials.gov ID
- NCT02747602
- Acronym / sponsor ID
- AC-16-011_BE
- Conditions
- Healthy
- Keywords
- Healthy volunteers, Caprylic triglyceride oil, AC-1204, Pharmacokinetic, Ketone body
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Apr 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 and β-hydroxybutyrate) levels after administration of AC-1204 versus caprylic triglyceride (CT) oil, both after a standard breakfast.
To evaluate the effect of a high fat diet on serum ketone body levels after administration of CT oil with a high fat breakfast versus a standard breakfast.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group ABC | Experimental | Drug: AC-1204, Drug: caprylic triglyceride oil (standard breakfast), Drug: caprylic triglyceride oil (high fat breakfast)AC-1204, caprylic triglyceride oil standard breakfast, caprylic triglyceride high fat breakfast |
| Group BCA | Experimental | Drug: AC-1204, Drug: caprylic triglyceride oil (standard breakfast), Drug: caprylic triglyceride oil (high fat breakfast)caprylic triglyceride oil standard breakfast, caprylic triglyceride high fat breakfast, AC-1204 |
| Group CAB | Experimental | Drug: AC-1204, Drug: caprylic triglyceride oil (standard breakfast), Drug: caprylic triglyceride oil (high fat breakfast)caprylic triglyceride high fat breakfast, AC-1204, caprylic triglyceride oil standard breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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 the first dose 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 triglycerides levels < 250 mg/dL.
- A non-vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to first dose/dosing of study drug. A subject who has been vasectomized less than 4 months prior to study first dose/dosing must follow the same restrictions as a non-vasectomized male).
Key exclusion criteria (19 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 the first dose/dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, 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 |
|---|---|---|
| AC-120440 g (120 mL) AC-1204 administered 30 minutes after the start of a standard breakfast. | Drug | Group ABC, Group BCA, Group CAB |
| caprylic triglyceride oil (standard breakfast)20 g CT oil (21 mL) administered 30 minutes after the start of a standard breakfast. | Drug | Group ABC, Group BCA, Group CAB |
| caprylic triglyceride oil (high fat breakfast)20 g CT oil (21 mL) administered 30 minutes after the start of a high fat breakfast. | Drug | Group ABC, Group BCA, Group CAB |
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 maximum 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 Tmax
Time frame: 0-24 hours
Time to reach Cmax. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value
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.
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 28 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Geri Poss, MD 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 AC-1204, caprylic triglyceride oil (standard breakfast) and caprylic triglyceride oil (high fat breakfast) 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 7 inclusion and 19 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 28 Oct 2016. 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 14 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 28 Oct 2016.