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

Study Identifier:
405-201-00102
ClinicalTrials.gov Identifier:
NCT07486895
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
Subscribe to Updates

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Centanafadine
Date
Mar 2023 - May 2023
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
  • 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.

Protocol 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.

Study Locations

Location
Status
Location
ICON plc
Lenexa, Kansas, United States, 66219
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion 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.

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