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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408780
• Other study ID #: AC-22-028
• Status: Completed
• Phase: Phase 1
• Start date: July 14, 2022
• Est. completion date: October 24, 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 PK, safety, and tolerability of a new liquid formulation of tricaprilin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 24, 2022
• Est. primary completion date: August 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• AC-OLE-01-VA
formulation of tricaprilin or matching placebo

Locations

Country	Name	City	State
United States	Quotient Sciences Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

United States, 

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 A)	AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)	0 to 8 hours post-dose
Primary	Incidence of Treatment Emergent Adverse Events (Part B)	Adverse event incidence will be tabulated	Baseline to 28 days
Secondary	Incidence of Treatment Emergent Adverse Events (Part A)	Adverse event incidence will be tabulated [BARF] Scale)	Baseline to 8 days
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 B)	AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)	0 to 8 hours post-dose
Secondary	Maximum observed concentration (Cmax) of total ketones (ß-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)	0 to 8 hours post-dose