Alzheimer DiseasePhase 1NCT03635879
Medical Food Formulation Pharmacokinetic (PK) Study in Medium Chain Triglycerides
A Phase 1 study testing MCTprocal medical food, Milk/tricaprilin oil blend and AC-1207 in people with Alzheimer Disease, run by Cerecin.
Trial summary
This is a Phase I, open label, randomized, 6-way crossover, pilot PK study 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
- Alzheimer Disease
- What is being tested?
- MCTprocal medical food, Milk/tricaprilin oil blend and AC-1207
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2019to 16 Apr 2019
- 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 based on self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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.
- Hemoglobin levels ≥ the lower limit of normal at Screening and Day -1 of Period 1.
- 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 year 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 symptomatic diverticular disease, uncontrolled gastroesophageal reflux disease, ulcers, inflammatory bowel disease, irritable bowel syndrome or recurrent diarrhea, or gout.
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- Positive urine drug results at Screening or Check-in.
- Positive alcohol results at Screening or Check-in. One repeat assessment is permitted.
- 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. One repeat assessment is permitted.
- 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 hours) 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.
- Has been following a ketogenic diet, in the opinion of the PI or designee, within 2 weeks prior to Day -1 of Period 1.
- Is lactose intolerant.
- Is unable to complete the standard breakfast prior to dosing on Day 1 of each Period.
- 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.
About this study
Official title: A Phase 1, Single-Center, Pilot, Single-Dose, 6-Way Crossover Study to Compare Six Formulations of Medium Chain Triglycerides on the Pharmacokinetics of Ketone Body Production
This is a Phase I, open label, randomized, 6-way crossover, pilot PK study
Read the detailed description
12 healthy, male subjects enrolled, subject will be randomized to receive a single dose of one of six treatment, with a 2 day washout in between each dosing period.
- Conditions
- Alzheimer Disease
- Being tested
- MCTprocal medical food, Milk/tricaprilin oil blend, AC-1207, AC-1205, AC-1206
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCTprocal medical foodOther
32 g MCTprocal (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
Milk/tricaprilin oil blendOther
154 mL of lactose-free skim milk/21 mL of tricaprilin oil blended and then mixed in 180 mL of water at Hour 0 Day 1
AC-1207Other
AC-1207 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
AC-1205Other
AC-1205 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
AC-1206Other
AC-1206 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
AC-1202Drug
AC-1202 (20 g MCT) mixed in 240 mL of water at Hour 0 Day 1
| Study group | Role | What they receive |
|---|---|---|
| MCTprocal medical food | Active comparator | Vitaflo MCTprocal, single dose (20 g MCT) Receives: Other: MCTprocal medical food |
| Milk/tricaprilin oil blend | Active comparator | Lactose-free milk and tricaprilin oil, blended,single dose (20 g tricaprilin) Receives: Other: Milk/tricaprilin oil blend |
| AC-1207 | Active comparator | AC-1207 liquid, single dose (20 g tricaprilin) Receives: Other: AC-1207 |
| AC-1205 | Active comparator | AC-1205 liquid, single dose (20 g tricaprilin) Receives: Other: AC-1205 |
| AC-1206 | Active comparator | AC-1206 liquid, single dose (20 g tricaprilin) Receives: Other: AC-1206 |
| AC-1202 | Experimental | AC-1206 liquid, single dose (20 g tricaprilin) Receives: Drug: AC-1202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ketones
Area Under the Curve (AUC) AUC 0 - last
Measured: 1 day
Total ketones
AUC 0 - 4
Measured: 1 day
Total ketones
AUC 0 - 6
Measured: 1 day
Total ketones
AUC 0 - 8
Measured: 1 day
Total ketones
Maximum Plasma Concentration (Cmax)
Measured: 1 day
B-hydroxybutyrate
AUC 0 - last
Measured: 1 day
B-hydroxybutyrate
AUC 0 - 4
Measured: 1 day
B-hydroxybutyrate
AUC 0 - 6
Measured: 1 day
B-hydroxybutyrate
AUC 0 - 8
Measured: 1 day
B-hydroxybutyrate
Cmax
Measured: 1 day
Acetoacetate
AUC 0 - last
Measured: 1 day
Acetoacetate
AUC 0 - 4
Measured: 1 day
Acetoacetate
AUC 0 - 6
Measured: 1 day
Acetoacetate
AUC 0 - 8
Measured: 1 day
Acetoacetate
Cmax
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start13 Feb 2019 (estimated)
- Primary completion16 Apr 2019 (estimated)
- Study completion16 Apr 2019 (estimated)
Why it stopped: Study redesign
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635879
- Sponsor's protocol ID
- AX-18-018_PK
- Status last verified
- Sep 2018
- First submitted
- 16 Aug 2018
- Last updated
- 27 Sep 2018
- 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Pilot, Single-Dose, 6-Way Crossover Study to Compare Six Formulations of Medium Chain Triglycerides on the Pharmacokinetics of Ketone Body Production
- ClinicalTrials.gov ID
- NCT03635879
- Acronym / sponsor ID
- AX-18-018_PK
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study redesign
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (estimated)
- Primary completion
- 16 Apr 2019 (estimated)
- Study completion
- 16 Apr 2019 (estimated)
- First posted
- 17 Aug 2018 (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.
This is a Phase I, open label, randomized, 6-way crossover, pilot PK study
Detailed description
12 healthy, male subjects enrolled, subject will be randomized to receive a single dose of one of six treatment, with a 2 day washout in between each dosing period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MCTprocal medical food | Active comparator | Other: MCTprocal medical foodVitaflo MCTprocal, single dose (20 g MCT) |
| Milk/tricaprilin oil blend | Active comparator | Other: Milk/tricaprilin oil blendLactose-free milk and tricaprilin oil, blended,single dose (20 g tricaprilin) |
| AC-1207 | Active comparator | Other: AC-1207AC-1207 liquid, single dose (20 g tricaprilin) |
| AC-1205 | Active comparator | Other: AC-1205AC-1205 liquid, single dose (20 g tricaprilin) |
| AC-1206 | Active comparator | Other: AC-1206AC-1206 liquid, single dose (20 g tricaprilin) |
| AC-1202 | Experimental | Drug: AC-1202AC-1206 liquid, single dose (20 g tricaprilin) |
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 Day -1 of Period 1 and throughout the study based on self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 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.
- Hemoglobin levels ≥ the lower limit of normal at Screening and Day -1 of Period 1.
Key exclusion criteria (21 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 year 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 |
|---|---|---|
| MCTprocal medical food32 g MCTprocal (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1 | Other | MCTprocal medical food |
| Milk/tricaprilin oil blend154 mL of lactose-free skim milk/21 mL of tricaprilin oil blended and then mixed in 180 mL of water at Hour 0 Day 1 | Other | Milk/tricaprilin oil blend |
| AC-1207AC-1207 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1 | Other | AC-1207 |
| AC-1205AC-1205 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1 | Other | AC-1205 |
| AC-1206AC-1206 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1 | Other | AC-1206 |
| AC-1202AC-1202 (20 g MCT) mixed in 240 mL of water at Hour 0 Day 1 | Drug | AC-1202 |
Primary outcome
Total ketones
Time frame: 1 day
Area Under the Curve (AUC) AUC 0 - last
Total ketones
Time frame: 1 day
AUC 0 - 4
Total ketones
Time frame: 1 day
AUC 0 - 6
Total ketones
Time frame: 1 day
AUC 0 - 8
Total ketones
Time frame: 1 day
Maximum Plasma Concentration (Cmax)
B-hydroxybutyrate
Time frame: 1 day
AUC 0 - last
B-hydroxybutyrate
Time frame: 1 day
AUC 0 - 4
B-hydroxybutyrate
Time frame: 1 day
AUC 0 - 6
B-hydroxybutyrate
Time frame: 1 day
AUC 0 - 8
B-hydroxybutyrate
Time frame: 1 day
Cmax
Acetoacetate
Time frame: 1 day
AUC 0 - last
Acetoacetate
Time frame: 1 day
AUC 0 - 4
Acetoacetate
Time frame: 1 day
AUC 0 - 6
Acetoacetate
Time frame: 1 day
AUC 0 - 8
Acetoacetate
Time frame: 1 day
Cmax
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCTprocal medical food, Milk/tricaprilin oil blend and AC-1207 in people with Alzheimer Disease, run by Cerecin.
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 21 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: withdrawn, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 1 day). The study lists 15 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 Sep 2018.