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

A Phase 1, Randomized, Open-label, Parallel-arm Trial to Assess Relative Bioavailability of Centanafadine Sustained-Release (SR) Tablet to Once-Daily Extended-Release (QD XR) Capsule Following Oral Administration in Healthy Adult Subjects

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Centanafadine SR; Drug: Centanafadine QD XR

• Study Type: Interventional
• Enrollment (Actual): 62
• 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 from 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).

2. In good health as determined by:

   • Medical history
   • Physical examination
   • Electrocardiogram (ECG)
   • 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. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
2. 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.
3. Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
4. 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.
5. History of any significant drug allergy or known or suspected hypersensitivity.
6. Any participant who, in the opinion of the investigator, should not participate in the trial.

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR; Participants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4.	Drug: Centanafadine SR; Oral tablets.; Other Names: EB-1020; Drug: Centanafadine QD XR; Oral capsules.; Other Names: EB-1020
Experimental: Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR; Participants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4.	Drug: Centanafadine SR; Oral tablets.; Other Names: EB-1020; Drug: Centanafadine QD XR; Oral capsules.; Other Names: EB-1020
Experimental: Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR; Participants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4.	Drug: Centanafadine SR; Oral tablets.; Other Names: EB-1020; Drug: Centanafadine QD XR; Oral capsules.; Other Names: EB-1020
Experimental: Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR; Participants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4.	Drug: Centanafadine SR; Oral tablets.; Other Names: EB-1020; Drug: Centanafadine QD XR; Oral capsules.; Other Names: EB-1020
Experimental: Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed; Participants receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fed state on Day 4.	Drug: Centanafadine QD XR; Oral capsules.; Other Names: EB-1020
Experimental: Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted; Participants receive CTN 328.8 mg, QD XR, capsule, orally in fed state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 4.	Drug: Centanafadine QD XR; Oral capsules.; Other Names: EB-1020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine	Up to Day 6
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine	Up to Day 6
Maximum Plasma Concentration (Cmax) of Centanafadine	Up to Day 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Maximum Plasma Concentration (Tmax) of Centanafadine	Up to Day 6
Terminal-phase Eimination Half-life (T1/2z) of Centanafadine	Up to Day 6
Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine	Up to Day 6
AUCt of Centanafadine Under Fasted and Fed Conditions	Up to Day 6
AUCinfinity of Centanafadine Under Fasted and Fed Conditions	Up to Day 6
Cmax of Centanafadine Under Fasted and Fed Conditions	Up to Day 6

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): March 26, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane
• Other Study ID Numbers: 405-201-00018

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