A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

Sponsor ID
405-201-00198
Clinicaltrials.gov ID
NCT07314333
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
405-201-00198
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • ADHD
    • Sex
    Female & Male
    Trial Dates
    Feb 2026 - Mar 2026
    Healthy Volunteers
    Yes
    • Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).
    • Must be in good health, based on:
    • Medical history
    • Physical examination
    • Heart test (Electrocardiogram \[ECG\])
    • Lab tests (blood, urine and other routine checks)
    • Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety.
    • Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.
    • History of drug and/or alcohol abuse in past 2 years.
    • History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
    • Known drug allergy or hypersensitivity.
    • Any history of significant bleeding problems.
    • Difficulty donating blood in the past.
    • Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine.
    • Uncontrolled high blood pressure (BP) (systolic blood pressure \[SBP\] \> 140 millimeters of mercury (mmHg) or diastolic blood pressure \[DBP\] \> 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing).
    • History of unexplained fainting (syncope).
    • Serious mental health disorders that could interfere with participation.

    Study Summary

    This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Centanafadine
    Type
    Interventional
    Masking
    Single
    Estimated Enrollment
    40
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).
    • * Must be in good health, based on:

    Exclusion Criteria

    • * History of drug and/or alcohol abuse in past 2 years.
    • * History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).
    • Must be in good health, based on:
    • Medical history
    • Physical examination
    • Heart test (Electrocardiogram \[ECG\])
    • Lab tests (blood, urine and other routine checks)
    • Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety.
    • Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.
    Exclusion Criteria:
    • History of drug and/or alcohol abuse in past 2 years.
    • History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
    • Known drug allergy or hypersensitivity.
    • Any history of significant bleeding problems.
    • Difficulty donating blood in the past.
    • Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine.
    • Uncontrolled high blood pressure (BP) (systolic blood pressure \[SBP\] \> 140 millimeters of mercury (mmHg) or diastolic blood pressure \[DBP\] \> 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing).
    • History of unexplained fainting (syncope).
    • Serious mental health disorders that could interfere with participation.

    Locations

    Location
    Status
    Location
    ICON
    Salt Lake City, Utah, United States, 84124
    Status
    N/A

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    January 2026 01US25EUC0489

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