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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05028114




Registration number
NCT05028114
Ethics application status
Date submitted
19/08/2021
Date registered
31/08/2021
Date last updated
17/10/2023

Titles & IDs
Public title
Tricaprilin Liquid Formulation PK Study
Scientific 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
Secondary ID [1] 0 0
AC-21-025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AC-1202
Treatment: Drugs - AC-OLE-01
Treatment: Drugs - AC-OLE-02
Treatment: Drugs - AC-OLE-03
Treatment: Drugs - AC-OLE-04
Treatment: Drugs - AC-OLE-05
Treatment: Drugs - AC-OLE-06
Treatment: Drugs - AC-OLE-07
Treatment: Drugs - AC-OLE-08
Treatment: Drugs - AC-OLE-09
Treatment: Drugs - AC-OLE-010
Treatment: Drugs - AC-OLE-P

Experimental: Part 1 (Formulation Optimisation) - 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.

Experimental: Part 2 (Placebo Assessment) - 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.

Experimental: Part 3 (Titration Tolerability) - 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.


Treatment: Drugs: AC-1202
Tricaprilin formulated as AC-1202

Treatment: Drugs: AC-OLE-01
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-02
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-03
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-04
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-05
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-06
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-07
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-08
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-09
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-010
Tricaprilin Formulation

Treatment: Drugs: AC-OLE-P
Placebo to tricaprilin formulation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the concentration-time curve (AUC) of total ketones (ß-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Timepoint [1] 0 0
0 to 8 hours post-dose
Primary outcome [2] 0 0
Maximum observed concentration (Cmax) of total ketones (ß-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Timepoint [2] 0 0
0 to 8 hours post-dose
Primary outcome [3] 0 0
Time of maximum concentration (Tmax) of total ketones (ß-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part 1, Part 2)
Timepoint [3] 0 0
0 to 8 hours post-dose
Secondary outcome [1] 0 0
Incidence of treatment emergent adverse events
Timepoint [1] 0 0
Baseline to end of treatment period
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Secondary outcome [4] 0 0
Area under the concentration-time curve (AUC) of total ketones (ß-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Timepoint [4] 0 0
Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Secondary outcome [5] 0 0
Maximum observed concentration (Cmax) of total ketones (ß-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Timepoint [5] 0 0
Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Secondary outcome [6] 0 0
Time of maximum concentration (Tmax) of total ketones (ß-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part 3)
Timepoint [6] 0 0
Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose

Eligibility
Key inclusion criteria
* 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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2022
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cerecin
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.
Trial website
https://clinicaltrials.gov/study/NCT05028114
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Cerecin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05028114