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

NCT07486895 | Completed Phase 1 FDA Drug

• 1 other identifier: 405-201-00102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Participants

Keywords

ADHD; Attention-deficit/hyperactivity disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR

EXPERIMENTAL

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

CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR

EXPERIMENTAL

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

Interventions

Centanafadine DRUG

Centanafadine will be administered as an oral capsule.

CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR; CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

ICON plc

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: March 8, 2023
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

Locations

US (1)