Tricaprilin Liquid Formulation PK Study

Cerecin

Status and phase: Terminated; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: AC-OLE-02; Drug: AC-OLE-010; Drug: AC-OLE-06; Drug: AC-OLE-09; Drug: AC-1202; Drug: AC-OLE-03; Drug: AC-OLE-08; Drug: AC-OLE-04; Drug: AC-OLE-05; Drug: AC-OLE-01; Drug: AC-OLE-P; Drug: AC-OLE-07

Study type: Interventional

Funder types: Industry

Identifiers

NCT05028114

AC-21-025

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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71 participants in 3 patient groups

Part 1 (Formulation Optimisation)

Experimental group

Description:

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.

Treatment:

Drug: AC-OLE-07

Drug: AC-OLE-06

Drug: AC-OLE-01

Drug: AC-OLE-010

Drug: AC-OLE-02

Drug: AC-OLE-05

Drug: AC-OLE-09

Drug: AC-OLE-04

Drug: AC-1202

Drug: AC-OLE-08

Drug: AC-OLE-03

Part 2 (Placebo Assessment)

Experimental group

Description:

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.

Treatment:

Drug: AC-OLE-P

Part 3 (Titration Tolerability)

Experimental group

Description:

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:

Drug: AC-OLE-P