Tricaprilin Liquid Formulation PK Study

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05028114
• Other study ID #: AC-21-025
• Status: Terminated
• Phase: Phase 1
• Start date: August 31, 2021
• Est. completion date: July 19, 2022

Study information

• Verified date: October 2023
• Source: Cerecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This is a three-part, part-randomised study that include single-dose, food effect, and titration tolerability in up to 80 healthy participants.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: July 19, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• AC-1202
Tricaprilin formulated as AC-1202
• AC-OLE-01
Tricaprilin Formulation
• AC-OLE-02
Tricaprilin Formulation
• AC-OLE-03
Tricaprilin Formulation
• AC-OLE-04
Tricaprilin Formulation
• AC-OLE-05
Tricaprilin Formulation
• AC-OLE-06
Tricaprilin Formulation
• AC-OLE-07
Tricaprilin Formulation
• AC-OLE-08
Tricaprilin Formulation
• AC-OLE-09
Tricaprilin Formulation
• AC-OLE-010
Tricaprilin Formulation
• AC-OLE-P
Placebo to tricaprilin formulation

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)	0 to 8 hours post-dose
Primary	Maximum observed concentration (Cmax) of total ketones (ß-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)	0 to 8 hours post-dose
Primary	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)	Tmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)	0 to 8 hours post-dose
Secondary	Incidence of treatment emergent adverse events	Adverse event incidence will be tabulated	Baseline to end of treatment period
Secondary	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.	Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Secondary	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)	Pre-dose, 0.5, 1, 1.5, 2, 3 hours post-dose
Secondary	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)	AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)	Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Secondary	Maximum observed concentration (Cmax) of total ketones (ß-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)	Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose
Secondary	Time of maximum concentration (Tmax) of total ketones (ß-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)	Days 15 and 21: 0 to 8 hours post-dose; Day 27: 0 to 24 hours post-dose