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

• Sponsor: Cerecin (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05408780
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.6
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: AC-OLE-01-VA	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jul 14, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A - Food Effect Assessment 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.	Drug: AC-OLE-01-VA; formulation of tricaprilin or matching placebo
Experimental: Part B - Titration Tolerability 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.	Drug: AC-OLE-01-VA; formulation of tricaprilin or matching placebo

Outcome Measures

Primary Outcome Measures

1. 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)

2. Incidence of Treatment Emergent Adverse Events (Part B) [Baseline to 28 days]

   Adverse event incidence will be tabulated

Secondary Outcome Measures

1. Incidence of Treatment Emergent Adverse Events (Part A) [Baseline to 8 days]

   Adverse event incidence will be tabulated [BARF] Scale)

2. 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)

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Miami	Miami	Florida	United States	33126

Sponsors and Collaborators

• Cerecin

Investigators

• Study Director: Study Director, Cerecin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerecin
• ClinicalTrials.gov Identifier: NCT05408780
• Other Study ID Numbers: AC-22-028
• First Posted: Jun 7, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Jul 19, 2022