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

Study Identifier:
405-201-00198
ClinicalTrials.gov Identifier:
NCT07314333
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Recruiting
Subscribe to Updates

Study Details

Medical Condition
  • ADHD
Study Drug
  • Drug: Centanafadine
  • Drug: Methylphenidate
  • Drug: Lisdexamfetamine
Date
Feb 2026 - Apr 2026
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
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.

Protocol 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.

Study Locations

Location
Status
Location
ICON
Salt Lake City, Utah, United States, 84124
Status
Recruiting
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
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.

We defy limitation,

so that others can too.

Follow Us
OAPI and OPDC Locations

508 Carnegie Center Dr,

Princeton, NJ 08540, United States

Phone 609-524-6788

2440 Research Blvd,

Rockville, MD 20850, United States

Phone 301-424-9055

3956 Point Eden Way

Hayward, CA 94545, United States

Phone 800-562-3974