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Completed

NCT Number: NCT07486895

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON plc

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Centanafadine

Drug

Centanafadine will be administered as an oral capsule.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Centanafadine

    Time frame: Up to Day 5

  2. Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine

    Time frame: Up to Day 5

  3. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine

    Time frame: Up to Day 5

Secondary outcomes

  1. Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine

    Time frame: Up to Day 5

  2. Percentage (%) of Extrapolated AUC of Centanafadine

    Time frame: Up to Day 5

  3. Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine

    Time frame: Up to Day 5

  4. Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine

    Time frame: Up to Day 5

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

An Open-label, Randomized, Crossover Trial in Healthy Subjects to Assess Dose Strength Equivalence Among 164.4 and 328.8 mg Strengths of Oral Centanafadine QD XR Capsules

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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