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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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AC-OLE-01-VA

About this trial

This is an interventional basic science trial for Alzheimer Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Quotient Sciences Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part A - Food Effect Assessment

Part B - Titration Tolerability

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Incidence of Treatment Emergent Adverse Events (Part B)

Adverse event incidence will be tabulated

Secondary Outcome Measures

Incidence of Treatment Emergent Adverse Events (Part A)

Adverse event incidence will be tabulated [BARF] Scale)

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)

AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Maximum observed concentration (Cmax) of total ketones (β-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)

Full Information

NCT ID

NCT05408780

First Posted

May 31, 2022

Last Updated

October 15, 2023

Sponsor

Cerecin

1. Study Identification

Unique Protocol Identification Number

NCT05408780

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

July 14, 2022 (Actual)

Primary Completion Date

August 13, 2022 (Actual)

Study Completion Date

October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cerecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

This is a two-part study. Part A (Food Effect Assessment): It is a randomized, double-blind (to IMP received), placebo-controlled, four-period, single-dose design. Subjects will be dosed in the fed state or the fasted state depending on the regimen. Part B (Titration Tolerability): Participants will be administered to either tricaprilin or a matching placebo.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A - Food Effect Assessment

Arm Type

Experimental

Arm Description

Arm Title

Part B - Titration Tolerability

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

AC-OLE-01-VA

Intervention Description

formulation of tricaprilin or matching placebo

Primary Outcome Measure Information:

Title

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)

Description

AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Time Frame

0 to 8 hours post-dose

Title

Incidence of Treatment Emergent Adverse Events (Part B)

Description

Adverse event incidence will be tabulated

Time Frame

Baseline to 28 days

Secondary Outcome Measure Information:

Title

Incidence of Treatment Emergent Adverse Events (Part A)

Description

Adverse event incidence will be tabulated [BARF] Scale)

Time Frame

Baseline to 8 days

Title

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)

Description

AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Time Frame

0 to 8 hours post-dose

Title

Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)

Description

Cmax will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)

Time Frame

0 to 8 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Cerecin

Official's Role

Study Director

Facility Information:

Facility Name

Quotient Sciences Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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