RecruitingPhase 1NCT07314333

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

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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Enrollment

42 participants

Start Date

Feb 5, 2026

Study Type

INTERVENTIONAL

Conditions

ADHD

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria8

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 Criteria9

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.

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Interventions

DRUGCentanafadine

Oral, QD XR capsules.

DRUGMethylphenidate

Oral tablets.

DRUGLisdexamfetamine

Oral capsules

Locations(1)

ICON

Salt Lake City, Utah, United States

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NCT07314333

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