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

NCT07314333 | Completed Phase 1 FDA Drug

• 1 other identifier: 405-201-00198
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD

Keywords

Attention-deficit/hyperactivity disorder; Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)

  Baseline, Day 12 or ET

• Change from Baseline in Heart Rate (HR) at Day 12 or ET

  Baseline, Day 12 or ET

Secondary Outcomes (7)

• Maximal peak plasma concentration (Cmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine

  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

  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

  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

  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

  Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose

Study Arms (6)

Arm 1, Sequence 1: ABC

EXPERIMENTAL

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; Drug: Methylphenidate

Arm 1, Sequence 2: BCA

EXPERIMENTAL

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; Drug: Methylphenidate

Arm 1, Sequence 3: CAB

EXPERIMENTAL

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; Drug: Methylphenidate

Arm 2, Sequence 1: ABC

EXPERIMENTAL

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; Drug: Lisdexamfetamine

Arm 2, Sequence 2: BCA

EXPERIMENTAL

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; Drug: Lisdexamfetamine

Arm 2, Sequence 3: CAB

EXPERIMENTAL

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; Drug: Lisdexamfetamine

Interventions

Centanafadine DRUG

Oral, QD XR capsules.

Also known as: EB-1020

Arm 1, Sequence 1: ABC; Arm 1, Sequence 2: BCA; Arm 1, Sequence 3: CAB; Arm 2, Sequence 1: ABC; Arm 2, Sequence 2: BCA; Arm 2, Sequence 3: CAB

Methylphenidate DRUG

Oral tablets.

Also known as: Concerta

Arm 1, Sequence 1: ABC; Arm 1, Sequence 2: BCA; Arm 1, Sequence 3: CAB

Lisdexamfetamine DRUG

Oral capsules

Also known as: Vynase

Arm 2, Sequence 1: ABC; Arm 2, Sequence 2: BCA; Arm 2, Sequence 3: CAB

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

ICON

Salt Lake City, Utah, 84124, United States

Location

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane; Methylphenidate; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: February 5, 2026
• Primary Completion: March 30, 2026
• Study Completion: April 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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 which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (1)