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

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

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 Overview

• Status: Completed
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: Centanafadine

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON plc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).

2. In good health as determined by:

   1. Medical history
   2. Physical examination
   3. Electrocardiogram (ECG)
   4. Serum/urine chemistry, hematology, and serology tests.
3. 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

1. 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.
2. History of drug and/or alcohol abuse within 2 years prior to screening.
3. 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.
4. History of any significant drug allergy or known or suspected hypersensitivity.
5. Participants having taken an investigational drug within 30 days prior to screening.
6. Previous exposure to centanafadine.
7. Any history of significant bleeding or hemorrhagic tendencies.
8. A history of difficulty in donating blood.
9. The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP).
10. 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.
11. Any participant who, in the opinion of the investigator, should not participate in the trial. Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR; Participants will first receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 1, followed by 2 × 164.4 mg centanafadine QD XR capsules administered orally once daily on Day 5.	Drug: Centanafadine; Centanafadine will be administered as an oral capsule.
Experimental: CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR; Participants will first receive 2 × 164.4 mg centanafadine QD XR capsule, orally on Day 1. Then, they will receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 5.	Drug: Centanafadine; Centanafadine will be administered as an oral capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax) of Centanafadine	Up to Day 5
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine	Up to Day 5
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine	Up to Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine	Up to Day 5
Percentage (%) of Extrapolated AUC of Centanafadine	Up to Day 5
Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine	Up to Day 5
Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine	Up to Day 5

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; Attention-deficit/hyperactivity disorder
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 405-201-00102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No