A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

April 29, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults

This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single dose crossover study. Participants in each arm will receive 3 treatments in a 3 -sequence, 3-period, crossover design. In each arm, participants will be randomized to 1 of 3 treatment sequences: Sequence 1: ABC, Sequence 2: BCA, or Sequence 3: CAB.

Here's what each treatment incudes:

  • Treatment A - centanafadine alone in both Arms 1 and 2.
  • Treatment B - methylphenidate alone in Arm 1 and lisdexamfetamine alone in Arm 2.
  • Treatment C - centanafadine combined with methylphenidate in Arm 1, and centanafadine combined with lisdexamfetamine in Arm 2.

The duration of trial participation for each participant will be approximately 44 days, and the overall trial duration is expected to be approximately 3 months.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • ICON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).

  • Must be in good health, based on:

    • Medical history
    • Physical examination
    • Heart test (Electrocardiogram [ECG])
    • Lab tests (blood, urine and other routine checks)
  • Willing to stay in the clinic for the required time and agree to a follow-up phone call for safety.
  • Able to sign informed consent and, in the investigator's opinion, follow all trial requirements.

Exclusion Criteria:

  • History of drug and/or alcohol abuse in past 2 years.
  • History of or current hepatitis or acquired immune deficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
  • Known drug allergy or hypersensitivity.
  • Any history of significant bleeding problems.
  • Difficulty donating blood in the past.
  • Use of tobacco or exposure to second-hand smoke in the past 2 months, or high cotinine levels in blood/urine.
  • Uncontrolled high blood pressure (BP) (systolic blood pressure [SBP] > 140 millimeters of mercury (mmHg) or diastolic blood pressure [DBP] > 90 mmHg) or symptomatic low blood pressure, or orthostatic hypotension (large BP drop when standing).
  • History of unexplained fainting (syncope).
  • Serious mental health disorders that could interfere with participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1, Sequence 1: ABC
Participants will receive dosing of centanafadine alone (A), once daily (QD) extended release (XR) capsule on Day 1 followed by methylphenidate alone (B), tablet, QD on Day 5, further followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.
Drug: Centanafadine
Oral, QD XR capsules.
Other Names:
  • EB-1020
Drug: Methylphenidate
Oral tablets.
Other Names:
  • Concerta
Experimental: Arm 1, Sequence 2: BCA
Participants will receive dosing of methylphenidate alone (B), tablet, QD on Day 1, followed by centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.
Drug: Centanafadine
Oral, QD XR capsules.
Other Names:
  • EB-1020
Drug: Methylphenidate
Oral tablets.
Other Names:
  • Concerta
Experimental: Arm 1, Sequence 3: CAB
Participants will receive dosing of centanafadine, QD XR capsule along with methylphenidate, tablet (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by methylphenidate alone, tablet (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.
Drug: Centanafadine
Oral, QD XR capsules.
Other Names:
  • EB-1020
Drug: Methylphenidate
Oral tablets.
Other Names:
  • Concerta
Experimental: Arm 2, Sequence 1: ABC
Participants will receive dosing of centanafadine alone, QD XR capsule (A) on Day 1 followed by lisdexamfetamine alone, capsule (B), QD on Day 5, further followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 9. There will be a washout period of 96 hours between each dosing.
Drug: Centanafadine
Oral, QD XR capsules.
Other Names:
  • EB-1020
Drug: Lisdexamfetamine
Oral capsules
Other Names:
  • Vynase
Experimental: Arm 2, Sequence 2: BCA
Participants will receive dosing of lisdexamfetamine alone, capsule (B), QD on Day 1, followed by centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 5, further followed by centanafadine alone, QD XR capsule (A) on Day 9. There will be a washout period of 96 hours between each dosing.
Drug: Centanafadine
Oral, QD XR capsules.
Other Names:
  • EB-1020
Drug: Lisdexamfetamine
Oral capsules
Other Names:
  • Vynase
Experimental: Arm 2, Sequence 3: CAB
Participants will receive dosing of centanafadine, QD XR capsule along with lisdexamfetamine, capsule (C), QD on Day 1, followed by centanafadine alone, QD XR capsule (A) on Day 5, further followed by lisdexamfetamine alone, capsule (B), QD on Day 9. There will be a washout period of 96 hours between each dosing.
Drug: Centanafadine
Oral, QD XR capsules.
Other Names:
  • EB-1020
Drug: Lisdexamfetamine
Oral capsules
Other Names:
  • Vynase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
Time Frame: Baseline, Day 12 or ET
Baseline, Day 12 or ET
Change from Baseline in Heart Rate (HR) at Day 12 or ET
Time Frame: Baseline, Day 12 or ET
Baseline, Day 12 or ET

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal peak plasma concentration (Cmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Area under the concentration time curve from time zero to the time of the last observable concentration at time (AUC0-12 hours) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Area under the concentration time curve from time zero to infinity (AUC-inf) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time to maximum (peak) Plasma Concentration (Tmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Terminal phase elimination half-life (t1/2,z) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Volume of distribution following extravascular administration (Vz/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Apparent clearance of drug from plasma after extravascular administration (CL/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Time Frame: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 405-201-00198

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 which can be found here: https://vivli.org/ourmember/Otsuka/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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