HealthyPhase 1NCT03063645
Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production
A Phase 1 study testing AC-1202, AC-SD-01 (50 g) and AC-SD-01 (75 g) 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 AC-1202 and 2 doses of AC-SD-01. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AC-1202, AC-SD-01 (50 g) and AC-SD-01 (75 g)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2017to 5 May 2017
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male 19-55 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 galactosemia or 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.
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- 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 subject 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 Hour 0 on Day -1 of Period 1 and prior to dosing on 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, 3-Way Crossover Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 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 AC-1202 and 2 doses of AC-SD-01.
- Conditions
- Healthy
- Being tested
- AC-1202, AC-SD-01 (50 g), AC-SD-01 (75 g)
- Keywords
- Healthy volunteer, AC-1202, AC-SD-01, Pharacokinetic, ketone body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-1202Drug
60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1
AC-SD-01 (50 g)Drug
50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
AC-SD-01 (75 g)Drug
75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group ABC | Experimental | AC-1202, AC-SD-01 (50g), AC-SD-01 (75g) Receives: Drug: AC-1202; Drug: AC-SD-01 (50 g); Drug: AC-SD-01 (75 g) |
| Group BCA | Experimental | AC-SD-01 (50g), AC-SD-01 (75g), AC-1202 Receives: Drug: AC-1202; Drug: AC-SD-01 (50 g); Drug: AC-SD-01 (75 g) |
| Group CAB | Experimental | AC-SD-01 (75g), AC-1202, AC-SD-01 (50g) Receives: Drug: AC-1202; Drug: AC-SD-01 (50 g); Drug: AC-SD-01 (75 g) |
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 hrs
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 hrs
total ketones AUC%extap
Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
Measured: 0-24 hrs
total ketones Cmax
Maximum observed concentration
Measured: 0-24 hrs
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., there or more non-zero serum concentrations)
Measured: 0-24 hrs
total ketones T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Measured: 0-24 hrs
total ketones Tmax
Time to reach Cmax. If the value occurs at more than one time points, Tmax is defined as the first time point with this value
Measured: 0-24 hrs
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 hrs
β hydroxybutyrate AUC0-inf
The area under the concentration time curve from time 0 extrapolated to infinity. AUC0inf is calculated as the sum of AUC0t plus the ratio of the last measurable serum concentration to the elimination rate constant.
Measured: 0-24 hrs
β hydroxybutyrate AUC%extap
Percent of AUC0-inf extrapolated, represented as (1 AUC0t/ AUC0inf)* 100
Measured: 0-24 hrs
β hydroxybutyrate Cmax
Maximum observed concentration
Measured: 0-24 hrs
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 nonzero serum concentrations)
Measured: 0-24 hrs
β hydroxybutyrate T 1/2
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
Measured: 0-24 hrs
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 hrs
estimate of acetoacetate AUC0-t
Difference between total ketones AUC0-t and total β hydroxybutyrate AUC0-t
Measured: 0-24 hrs
estimate of acetoacetate AUC0-inf
Difference between total ketones AUC0-inf and total β hydroxybutyrate AUC0-inf
Measured: 0-24 hrs
estimate of acetoacetate AUC%extap
Difference between total ketones AUC%extap and total β hydroxybutyrate AUC%extap
Measured: 0-24 hrs
estimate of acetoacetate Cmax
Difference between total ketones Cmax and total β hydroxybutyrate Cmax
Measured: 0-24 hrs
estimate of acetoacetate Kel
Difference between total ketones Kel and total β hydroxybutyrate Kel
Measured: 0-24 hrs
estimate of acetoacetate T 1/2
Difference between total ketones T 1/2 and total β hydroxybutyrate T 1/2
Measured: 0-24 hrs
estimate of acetoacetate Tmax
Difference between total ketones Tmax and total β hydroxybutyrate Tmax
Measured: 0-24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start11 Mar 2017
- Primary completion7 Apr 2017
- Study completion5 May 2017
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
- Model description
- 16 healthy subjects enrolled, each subject will receive 1 dose of each treatment, with a 2 day washout in between.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Charles Tomek, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063645
- Sponsor's protocol ID
- AC-17-014_BE
- Status last verified
- Jun 2017
- First submitted
- 21 Feb 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. 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 Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production
- ClinicalTrials.gov ID
- NCT03063645
- Acronym / sponsor ID
- AC-17-014_BE
- Conditions
- Healthy
- Keywords
- Healthy volunteer, AC-1202, AC-SD-01, Pharacokinetic, ketone body
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 24 Feb 2017 (actual)
- 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 AC-1202 and 2 doses of AC-SD-01.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 16 healthy subjects enrolled, each subject will receive 1 dose of each treatment, with a 2 day washout in between.
| Arm | Type | Receives |
|---|---|---|
| Group ABC | Experimental | Drug: AC-1202, Drug: AC-SD-01 (50 g), Drug: AC-SD-01 (75 g)AC-1202, AC-SD-01 (50g), AC-SD-01 (75g) |
| Group BCA | Experimental | Drug: AC-1202, Drug: AC-SD-01 (50 g), Drug: AC-SD-01 (75 g)AC-SD-01 (50g), AC-SD-01 (75g), AC-1202 |
| Group CAB | Experimental | Drug: AC-1202, Drug: AC-SD-01 (50 g), Drug: AC-SD-01 (75 g)AC-SD-01 (75g), AC-1202, AC-SD-01 (50g) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, adult, male 19-55 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 galactosemia or 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 |
|---|---|---|
| AC-120260 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1 | Drug | Group ABC, Group BCA, Group CAB |
| AC-SD-01 (50 g)50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1 | Drug | Group ABC, Group BCA, Group CAB |
| AC-SD-01 (75 g)75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1 | Drug | Group ABC, Group BCA, Group CAB |
Primary outcome
total ketones AUC0-t
Time frame: 0-24 hrs
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 hrs
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 hrs
Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
total ketones Cmax
Time frame: 0-24 hrs
Maximum observed concentration
total ketones Kel
Time frame: 0-24 hrs
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., there or more non-zero serum concentrations)
total ketones T 1/2
Time frame: 0-24 hrs
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
total ketones Tmax
Time frame: 0-24 hrs
Time to reach Cmax. If the value occurs at more than one time points, Tmax is defined as the first time point with this value
β hydroxybutyrate AUC0-t
Time frame: 0-24 hrs
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 hrs
The area under the concentration time curve from time 0 extrapolated to infinity. AUC0inf is calculated as the sum of AUC0t plus the ratio of the last measurable serum concentration to the elimination rate constant.
β hydroxybutyrate AUC%extap
Time frame: 0-24 hrs
Percent of AUC0-inf extrapolated, represented as (1 AUC0t/ AUC0inf)* 100
β hydroxybutyrate Cmax
Time frame: 0-24 hrs
Maximum observed concentration
β hydroxybutyrate Kel
Time frame: 0-24 hrs
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 nonzero serum concentrations)
β hydroxybutyrate T 1/2
Time frame: 0-24 hrs
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
β hydroxybutyrate Tmax
Time frame: 0-24 hrs
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 hrs
Difference between total ketones AUC0-t and total β hydroxybutyrate AUC0-t
estimate of acetoacetate AUC0-inf
Time frame: 0-24 hrs
Difference between total ketones AUC0-inf and total β hydroxybutyrate AUC0-inf
estimate of acetoacetate AUC%extap
Time frame: 0-24 hrs
Difference between total ketones AUC%extap and total β hydroxybutyrate AUC%extap
estimate of acetoacetate Cmax
Time frame: 0-24 hrs
Difference between total ketones Cmax and total β hydroxybutyrate Cmax
estimate of acetoacetate Kel
Time frame: 0-24 hrs
Difference between total ketones Kel and total β hydroxybutyrate Kel
estimate of acetoacetate T 1/2
Time frame: 0-24 hrs
Difference between total ketones T 1/2 and total β hydroxybutyrate T 1/2
estimate of acetoacetate Tmax
Time frame: 0-24 hrs
Difference between total ketones Tmax and total β hydroxybutyrate Tmax
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 27 Jun 2017.
- 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.
Charles Tomek, 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-1202, AC-SD-01 (50 g) and AC-SD-01 (75 g) 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 27 Jun 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 hrs). 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 27 Jun 2017.