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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: AC-OLE-01-VA

• Registration Number: NCT05408780
• Lead Sponsor: Cerecin

Brief Summary

The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-07
• Study Start: 2022-07-14
• Primary Completion: 2022-08-13
• Study Completion: 2022-10-24
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-15
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part B - Titration Tolerability	AC-OLE-01-VA	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.
Part A - Food Effect Assessment	AC-OLE-01-VA	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.

Primary Outcome Measures

Name	Time	Method
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)	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)	Baseline to 28 days	Adverse event incidence will be tabulated

Secondary Outcome Measures

Name	Time	Method
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)	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 A)	Baseline to 8 days	Adverse event incidence will be tabulated \[BARF\] Scale)
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)	0 to 8 hours post-dose	Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Trial Locations

Locations (1)

Quotient Sciences Miami; 🇺🇸 Miami, Florida, United States