A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine

Study Identifier:
405-201-00018
ClinicalTrials.gov Identifier:
NCT07465731
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Study Details

Medical Condition
  • Healthy Volunteers
Study Drug
  • Drug: Centanafadine SR
  • Drug: Centanafadine QD XR
Date
Oct 2022 - Mar 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
  • Body mass index from 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
  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
  • 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.
  • Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
  • History of any significant drug allergy or known or suspected hypersensitivity.
  • Any participant who, in the opinion of the investigator, should not participate in the trial.

Protocol Summary

The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN 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
  • Body mass index from 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
  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
  • 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.
  • Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
  • History of any significant drug allergy or known or suspected hypersensitivity.
  • Any participant who, in the opinion of the investigator, should not participate in the trial.

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