A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine

Sponsor ID
405-201-00018
Clinicaltrials.gov ID
NCT07465731
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00018
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Female & Male
    Trial Dates
    Oct 2022 - Mar 2023
    Healthy Volunteers
    Yes
    • Body mass index from 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
    • In good health as determined by:
    • Medical history
    • Physical examination
    • Electrocardiogram (ECG)
    • Serum/urine chemistry, hematology, and serology tests.
    • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
    • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
    • Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
    • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity.
    • Any participant who, in the opinion of the investigator, should not participate in the trial.

    Study Summary

    The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Centanafadine SR
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    62
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Body mass index from 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
    • 2. In good health as determined by:

    Exclusion Criteria

    • 1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
    • 2. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Body mass index from 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
    • In good health as determined by:
    • Medical history
    • Physical examination
    • Electrocardiogram (ECG)
    • Serum/urine chemistry, hematology, and serology tests.
    • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    Exclusion Criteria:
    • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
    • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
    • Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
    • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity.
    • Any participant who, in the opinion of the investigator, should not participate in the trial.

    Locations

    Location
    Status
    Location
    ICON, plc.,
    Lenexa, Kansas, United States, 66219
    Status
    N/A

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