Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects

Sponsor ID
405-201-00102
Clinicaltrials.gov ID
NCT07486895
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00102
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Female & Male
    Trial Dates
    Mar 2023 - May 2023
    Healthy Volunteers
    Yes
    • Inclusion Criteria
    • Body mass index (BMI) between 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
    • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
    • History of drug and/or alcohol abuse within 2 years prior to screening.
    • History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity.
    • Participants having taken an investigational drug within 30 days prior to screening.
    • Previous exposure to centanafadine.
    • Any history of significant bleeding or hemorrhagic tendencies.
    • A history of difficulty in donating blood.
    • The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP).
    • Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP.
    • Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Study Summary

    The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Centanafadine
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    44
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria
    • 1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Inclusion Criteria
    • Body mass index (BMI) between 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
    • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
    • History of drug and/or alcohol abuse within 2 years prior to screening.
    • History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity.
    • Participants having taken an investigational drug within 30 days prior to screening.
    • Previous exposure to centanafadine.
    • Any history of significant bleeding or hemorrhagic tendencies.
    • A history of difficulty in donating blood.
    • The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP).
    • Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP.
    • Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Locations

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

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