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Completed

NCT Number: NCT05408780

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Miami

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC-OLE-01-VA

Drug

formulation of tricaprilin or matching placebo

Primary outcomes

  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)

    Time frame: 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)

    Time frame: Baseline to 28 days

    Adverse event incidence will be tabulated

Secondary outcomes

  1. Incidence of Treatment Emergent Adverse Events (Part A)

    Time frame: 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)

    Time frame: 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)

    Time frame: 0 to 8 hours post-dose

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

Sponsors and collaborators

Lead sponsor

Cerecin

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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