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Completed

NCT Number: NCT07314333

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON

Salt Lake City, Utah, 84124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Centanafadine

Drug

Oral, QD XR capsules.

Other names: EB-1020

Methylphenidate

Drug

Oral tablets.

Other names: Concerta

Lisdexamfetamine

Drug

Oral capsules

Other names: Vynase

Primary outcomes

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

    Time frame: Baseline, Day 12 or ET

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

    Time frame: Baseline, Day 12 or ET

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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