Alzheimer DiseasePhase 1NCT05028114
Tricaprilin Liquid Formulation PK Study
A Phase 1 study testing AC-1202, AC-OLE-01 and AC-OLE-02 in people with Alzheimer Disease, run by Cerecin at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AC-1202, AC-OLE-01 and AC-OLE-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Aug 2021to 19 Jul 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).
- Male and female
- Agrees to comply with study procedures including blood draws, confinement to clinic, meal requirements
- Continuous non-smoker or infrequent smoker (no more than 10 cigarettes per week for at least 3 months prior to Screening)
Who cannot join
- History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen [up to 2 g per day], hormone replacement therapy and hormonal contraception are permitted).
- Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Three-part, Part-randomised, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Different Formulations of Tricaprilin, to Include Single-dose, Food Effect, and Titration Tolerability, in Healthy Participants
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.
- Conditions
- Alzheimer Disease
- Being tested
- AC-1202, AC-OLE-01, AC-OLE-02, AC-OLE-03, AC-OLE-04
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-1202Drug
Tricaprilin formulated as AC-1202
AC-OLE-01Drug
Tricaprilin Formulation
AC-OLE-02Drug
Tricaprilin Formulation
AC-OLE-03Drug
Tricaprilin Formulation
AC-OLE-04Drug
Tricaprilin Formulation
AC-OLE-05Drug
Tricaprilin Formulation
AC-OLE-06Drug
Tricaprilin Formulation
AC-OLE-07Drug
Tricaprilin Formulation
AC-OLE-08Drug
Tricaprilin Formulation
AC-OLE-09Drug
Tricaprilin Formulation
AC-OLE-010Drug
Tricaprilin Formulation
AC-OLE-PDrug
Placebo to tricaprilin formulation
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Formulation Optimisation) | Experimental | Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided 30 minutes after study drug administration. There will be 4 different formulations of the study drug and participants will be randomised to one of 4 sequences. There will be a washout of 2 days between each administration. Receives: Drug: AC-1202; Drug: AC-OLE-01; Drug: AC-OLE-02; Drug: AC-OLE-03; Drug: AC-OLE-04; Drug: AC-OLE-05; Drug: AC-OLE-06; Drug: AC-OLE-07; Drug: AC-OLE-08; Drug: AC-OLE-09; Drug: AC-OLE-010 |
| Part 2 (Placebo Assessment) | Experimental | Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment.
Participants are randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods. Receives: Drug: AC-OLE-P |
| Part 3 (Titration Tolerability) | Experimental | Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment.
Participants will be randomised to either study drug or the matching placebo. Receives: Drug: AC-OLE-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: 0 to 8 hours post-dose
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: 0 to 8 hours post-dose
Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Tmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: 0 to 8 hours post-dose
Secondary outcomes (6)
Incidence of treatment emergent adverse events
Adverse event incidence will be tabulated
Measured: Baseline to end of treatment period
Gastrointestinal side effects of single-dose administration of each of tricaprilin formulations and the placebo formulation (Parts 1, 2) assessed using the Baxter Retching Faces Scale
The Baxter Retching Faces Scale is a pictorial scale rated from 0 to 10, with 6 faces depicting level of nausea/gastrointestinal discomfort.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Gastrointestinal side effects of single-dose administration of each of tricaprilin formulations and the placebo formulation (Parts 1, 2) assessed using the Pain Numerical Rating Scale
The Pain Numerical Rating Scale 10-point numeric rating scale with participants instructed to rate any abdominal pain from 0 (no pain) to 10 (worst possible pain)
Measured: Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Tmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start31 Aug 2021
- Primary completion18 Mar 2022
- Study completion19 Jul 2022
Why it stopped: Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty.
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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a three-part study. Part 1 (Formulation Optimisation): Participants will be assigned to all 4 different formulations of tricaprilin, with randomization to one of 4 sequences with a 2-day washout in between different formulations. There are 2 series in this part. Part 1 (Food Effect): Participants will be administered to 1 formulation of tricaprilin. There are 2 series in this part. Part 2 (Placebo Assessment): Participants will be randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods. Part 3 (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Cerecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028114
- Sponsor's protocol ID
- AC-21-025
- Status last verified
- Oct 2023
- First submitted
- 19 Aug 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Three-part, Part-randomised, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Different Formulations of Tricaprilin, to Include Single-dose, Food Effect, and Titration Tolerability, in Healthy Participants
- ClinicalTrials.gov ID
- NCT05028114
- Acronym / sponsor ID
- AC-21-025
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 31 Aug 2021 (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.
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of new liquid formulations of tricaprilin, with the aim of finding a suitable formulation to advance in development. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a three-part study. Part 1 (Formulation Optimisation): Participants will be assigned to all 4 different formulations of tricaprilin, with randomization to one of 4 sequences with a 2-day washout in between different formulations. There are 2 series in this part. Part 1 (Food Effect): Participants will be administered to 1 formulation of tricaprilin. There are 2 series in this part. Part 2 (Placebo Assessment): Participants will be randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods. Part 3 (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Formulation Optimisation) | Experimental | Drug: AC-1202, Drug: AC-OLE-01, Drug: AC-OLE-02, Drug: AC-OLE-03, Drug: AC-OLE-04, Drug: AC-OLE-05, Drug: AC-OLE-06, Drug: AC-OLE-07, Drug: AC-OLE-08, Drug: AC-OLE-09, Drug: AC-OLE-010Study drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided 30 minutes after study drug administration. There will be 4 different formulations of the study drug and participants will be randomised to one of 4 sequences. There will be a washout of 2 days between each administration. |
| Part 2 (Placebo Assessment) | Experimental | Drug: AC-OLE-PStudy drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment. Participants are randomised to 1 of 2 sequences (tricaprilin formulation - matching placebo; matching placebo - tricaprilin formulation) with a 2-day washout between periods. |
| Part 3 (Titration Tolerability) | Experimental | Drug: AC-OLE-PStudy drug administered orally after an overnight fast (minimum 8 hours). A standard breakfast will be provided either 30 minutes before or after study drug administration, depending on the results of the food effect assessment. Participants will be randomised to either study drug or the matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy (in the opinion of the Investigator) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight ≥45 kg and body mass index (BMI) within the range 18.0 - 32.0 kg/m2 (inclusive).
- Male and female
- Agrees to comply with study procedures including blood draws, confinement to clinic, meal requirements
Key exclusion criteria (3 listed)
- History of, or current gastrointestinal (GI) conditions constituting a risk when taking the study treatment; or interfering with the interpretation of data, based on the Investigator's judgement
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing (paracetamol/acetaminophen [up to 2 g per day], hormone replacement therapy and hormonal contraception are permitted).
- Participants on a ketogenic diet, low-fat diet or actively using medium chain triglycerides, ketone esters, or other ketogenic products.
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-1202Tricaprilin formulated as AC-1202 | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-01Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-02Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-03Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-04Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-05Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-06Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-07Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-08Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-09Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-010Tricaprilin Formulation | Drug | Part 1 (Formulation Optimisation) |
| AC-OLE-PPlacebo to tricaprilin formulation | Drug | Part 2 (Placebo Assessment), Part 3 (Titration Tolerability) |
Primary outcome
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Time frame: 0 to 8 hours post-dose
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Time frame: 0 to 8 hours post-dose
Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Time frame: 0 to 8 hours post-dose
Tmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
6 secondary outcomes
Incidence of treatment emergent adverse events
Time frame: Baseline to end of treatment period
Gastrointestinal side effects of single-dose administration of each of tricaprilin formulations and the placebo formulation (Parts 1, 2) assessed using the Baxter Retching Faces Scale
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Gastrointestinal side effects of single-dose administration of each of tricaprilin formulations and the placebo formulation (Parts 1, 2) assessed using the Pain Numerical Rating Scale
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Time frame: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Time frame: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Time of maximum concentration (Tmax) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Time frame: Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Results and safety
The study was stopped early (reason given: Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
Study Director study director
Cerecin
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-OLE-01 and AC-OLE-02 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 6 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: stopped early, as of the sponsor's last update on 17 Oct 2023. 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 was stopped early (reason given: Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty.). Results are not available in the source record.
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?
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2) (time frame: 0 to 8 hours post-dose). The study lists 3 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 17 Oct 2023.