A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels

Sponsor ID
405-201-00157
Clinicaltrials.gov ID
NCT07253441
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00157
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • ADHD
    • Sex
    Female & Male
    Trial Dates
    Aug 2024 - Dec 2024
    Healthy Volunteers
    Yes
    • 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 investigator, to comply with all the requirements of the trial.
    • 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. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
    • History of drug and/or alcohol abuse within 2 years prior to screening.
    • History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity.
    • A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site.
    • 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 evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: CTN XR (TBM)
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    174
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

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

    Exclusion Criteria

    • 1. 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. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
    • 2. History of drug and/or alcohol abuse within 2 years prior to screening.
    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 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 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. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
    • History of drug and/or alcohol abuse within 2 years prior to screening.
    • History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity.
    • A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site.
    • 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 Lenexa
    Lenexa, Kansas, United States, 66219
    Status
    N/A
    Location
    ICON Salt Lake City
    Millcreek, Utah, United States, 84124
    Status
    N/A

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    January 2026 01US25EUC0489

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