Alzheimer DiseasePhase 1NCT03551769
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
A Phase 1 study testing tricaprilin, standard meal and high-fat meal in people with Alzheimer Disease, run by Cerecin at 1 site in Australia.
Trial summary
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects. 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?
- tricaprilin, standard meal and high-fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Aug 2018to 27 Aug 2018
- 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, ages 18 - 55
- Able to consume a regular diet and one high fat meal; no specific dietary requirements
- Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage
Who cannot join
- Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject
- Has been on a ketogenic diet as supported by review of a food diary
- Has positive Urine Drug Screen or alcohol results at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
- Conditions
- Alzheimer Disease
- Being tested
- tricaprilin, standard meal, high-fat meal, overnight fast
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tricaprilinDrug
Tricaprilin formulated as AC-SD-01
standard mealOther
standard meal
high-fat mealOther
high-fat meal
overnight fastOther
fasting for at least 9 hours
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Period 1 | Experimental | Study drug administered concurrently with a standard meal Receives: Drug: tricaprilin; Other: standard meal |
| Cohort 1, Period 2 | Experimental | Study drug administered 30 minutes after a standard meal Receives: Drug: tricaprilin; Other: standard meal |
| Cohort 1, Period 3 | Experimental | Study drug administered 30 minutes after a high-fat meal Receives: Drug: tricaprilin; Other: high-fat meal |
| Cohort 1, Period 4 | Experimental | Study drug administered after an overnight fast Receives: Drug: tricaprilin |
| Cohort 2, Period 1 | Experimental | Study drug administered 30 minutes after a standard meal (Asian) Receives: Drug: tricaprilin; Other: standard meal |
| Cohort 2, Period 2 | Experimental | Study drug administered after an overnight fast (Asian) Receives: Drug: tricaprilin; Other: overnight fast |
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-hydrodxybutyrate
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
Secondary outcomes (16)
tricaprilin
AUC 0 - last
Measured: 1 day
tricaprilin
AUC 0 - 4
Measured: 1 day
tricaprilin
AUC 0 - 6
Measured: 1 day
tricaprilin
AUC 0 - 8
Measured: 1 day
tricaprilin
Time to maximum concentration (Tmax)
Measured: 1 day
tricaprilin
Cmax
Measured: 1 day
octanoic acid
AUC 0 - last
Measured: 1 day
octanoic acid
AUC 0 - 4
Measured: 1 day
octanoic acid
AUC 0 - 6
Measured: 1 day
octanoic acid
AUC 0 - 8
Measured: 1 day
octanoic acid
Tmax
Measured: 1 day
octanoic acid
Cmax
Measured: 1 day
Computerized Cognitive Battery - Attention
Rapid Visual Information Processing Test
Measured: 1 day
Computerized Cognitive Battery - Episodic Memory
Paired Associates Learning Test
Measured: 1 day
Computerized Cognitive Battery - Working Memory
Spatial Working Memory Test
Measured: 1 day
Computerized Cognitive Battery - Psychomotor Function
Reaction Time Test
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 posted11 Jun 2018
- Study start5 Aug 2018
- Primary completion16 Aug 2018
- Study completion27 Aug 2018
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551769
- Sponsor's protocol ID
- AC-18-016_FE
- Status last verified
- May 2019
- First submitted
- 17 May 2018
- Last updated
- 29 May 2019
- Results posted
- 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 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
- ClinicalTrials.gov ID
- NCT03551769
- Acronym / sponsor ID
- AC-18-016_FE
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 11 Jun 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, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Period 1 | Experimental | Drug: tricaprilin, Other: standard mealStudy drug administered concurrently with a standard meal |
| Cohort 1, Period 2 | Experimental | Drug: tricaprilin, Other: standard mealStudy drug administered 30 minutes after a standard meal |
| Cohort 1, Period 3 | Experimental | Drug: tricaprilin, Other: high-fat mealStudy drug administered 30 minutes after a high-fat meal |
| Cohort 1, Period 4 | Experimental | Drug: tricaprilinStudy drug administered after an overnight fast |
| Cohort 2, Period 1 | Experimental | Drug: tricaprilin, Other: standard mealStudy drug administered 30 minutes after a standard meal (Asian) |
| Cohort 2, Period 2 | Experimental | Drug: tricaprilin, Other: overnight fastStudy drug administered after an overnight fast (Asian) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult male, ages 18 - 55
- Able to consume a regular diet and one high fat meal; no specific dietary requirements
- Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage
Key exclusion criteria (3 listed)
- Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject
- Has been on a ketogenic diet as supported by review of a food diary
- Has positive Urine Drug Screen or alcohol results at Screening
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 |
|---|---|---|
| tricaprilinTricaprilin formulated as AC-SD-01 | Drug | Cohort 1, Period 1, Cohort 1, Period 2, Cohort 1, Period 3, Cohort 1, Period 4, Cohort 2, Period 1, Cohort 2, Period 2 |
| standard mealstandard meal | Other | Cohort 1, Period 1, Cohort 1, Period 2, Cohort 2, Period 1 |
| high-fat mealhigh-fat meal | Other | Cohort 1, Period 3 |
| overnight fastfasting for at least 9 hours | Other | Cohort 2, Period 2 |
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-hydrodxybutyrate
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
16 secondary outcomes
tricaprilin
Time frame: 1 day
tricaprilin
Time frame: 1 day
tricaprilin
Time frame: 1 day
tricaprilin
Time frame: 1 day
tricaprilin
Time frame: 1 day
tricaprilin
Time frame: 1 day
octanoic acid
Time frame: 1 day
octanoic acid
Time frame: 1 day
octanoic acid
Time frame: 1 day
octanoic acid
Time frame: 1 day
octanoic acid
Time frame: 1 day
octanoic acid
Time frame: 1 day
Computerized Cognitive Battery - Attention
Time frame: 1 day
Computerized Cognitive Battery - Episodic Memory
Time frame: 1 day
Computerized Cognitive Battery - Working Memory
Time frame: 1 day
Computerized Cognitive Battery - Psychomotor Function
Time frame: 1 day
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 29 May 2019.
- 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.
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 tricaprilin, standard meal and high-fat meal in people with Alzheimer Disease, run by Cerecin at 1 site in Australia.
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 3 inclusion and 3 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 29 May 2019. 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 Australia. 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 (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 29 May 2019.