Alzheimer DiseasePhase 1NCT05408780
A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects
A Phase 1 study testing AC-OLE-01-VA in people with Alzheimer Disease, run by Cerecin at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AC-OLE-01-VA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 24 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Healthy males and non-pregnant, non-lactating healthy females aged 18 to 55 years inclusive at time of signing informed consent with a body weight ≥55 kg.
- Body mass index (BMI) 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
Main Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Subjects with a history of fainting, dizziness, bradycardia or hypotension as considered clinically significant by the investigator
- Subject has a medical condition that may adversely affect taste or smell activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects
The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.
- Conditions
- Alzheimer Disease
- Being tested
- AC-OLE-01-VA
- 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-OLE-01-VADrug
formulation of tricaprilin or matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - Food Effect Assessment | Experimental | Subjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods. Receives: Drug: AC-OLE-01-VA |
| Part B - Titration Tolerability | Experimental | Subjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch.
Participants will be randomised to either study drug or the matching placebo. Receives: Drug: AC-OLE-01-VA |
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 A)
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: 0 to 8 hours post-dose
Incidence of Treatment Emergent Adverse Events (Part B)
Adverse event incidence will be tabulated
Measured: Baseline to 28 days
Secondary outcomes (3)
Incidence of Treatment Emergent Adverse Events (Part A)
Adverse event incidence will be tabulated [BARF] Scale)
Measured: Baseline to 8 days
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)
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 administration of tricaprilin and placebo formulations (Part A, Part B)
Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Measured: 0 to 8 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 posted7 Jun 2022
- Study start14 Jul 2022
- Primary completion13 Aug 2022
- Study completion24 Oct 2022
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 two-part study. Part A (Food Effect Assessment): It is a randomized, double-blind (to IMP received), placebo-controlled, four-period, single-dose design. Subjects will be dosed in the fed state or the fasted state depending on the regimen. Part B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 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
- NCT05408780
- Sponsor's protocol ID
- AC-22-028
- Status last verified
- Oct 2023
- First submitted
- 31 May 2022
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05408780
- Acronym / sponsor ID
- AC-22-028
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 13 Aug 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 7 Jun 2022 (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 PK, safety, and tolerability of a new liquid formulation of tricaprilin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-part study. Part A (Food Effect Assessment): It is a randomized, double-blind (to IMP received), placebo-controlled, four-period, single-dose design. Subjects will be dosed in the fed state or the fasted state depending on the regimen. Part B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Part A - Food Effect Assessment | Experimental | Drug: AC-OLE-01-VASubjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods. |
| Part B - Titration Tolerability | Experimental | Drug: AC-OLE-01-VASubjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch. Participants will be randomised to either study drug or the matching placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-OLE-01-VAformulation of tricaprilin or matching placebo | Drug | Part A - Food Effect Assessment, Part B - 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 A)
Time frame: 0 to 8 hours post-dose
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Incidence of Treatment Emergent Adverse Events (Part B)
Time frame: Baseline to 28 days
Adverse event incidence will be tabulated
3 secondary outcomes
Incidence of Treatment Emergent Adverse Events (Part A)
Time frame: Baseline to 8 days
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)
Time frame: 0 to 8 hours post-dose
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)
Time frame: 0 to 8 hours post-dose
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 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-OLE-01-VA in people with Alzheimer Disease, 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?
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 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 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?
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A) (time frame: 0 to 8 hours post-dose). The study lists 2 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; AzTrials last refreshed its copy on 27 Oct 2026.