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

NCT05408780 | Completed Phase 1 FDA Drug

• 1 other identifier: AC-22-028
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• 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)

  0 to 8 hours post-dose

• Incidence of Treatment Emergent Adverse Events (Part B)

  Adverse event incidence will be tabulated

  Baseline to 28 days

Secondary Outcomes (3)

• Incidence of Treatment Emergent Adverse Events (Part A)

  Baseline to 8 days

• 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

• 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

Study Arms (2)

Part A - Food Effect Assessment

EXPERIMENTAL

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

Part B - Titration Tolerability

EXPERIMENTAL

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

Interventions

AC-OLE-01-VA DRUG

formulation of tricaprilin or matching placebo

Part A - Food Effect Assessment; Part B - Titration Tolerability

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerecin: lead

Study Sites (1)

Quotient Sciences Miami

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Study Director

  Cerecin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 7, 2022
• Study Start: July 14, 2022
• Primary Completion: August 13, 2022
• Study Completion: October 24, 2022
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)