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

Plain Language Summary

Simplified for easier understanding

This Phase 1 crossover study is testing how centanafadine — a drug being developed for ADHD — interacts in the body when taken together with stimulant medications (methylphenidate or lisdexamfetamine), which are commonly prescribed for the same condition. Researchers want to know if combining these drugs affects their absorption, distribution, and elimination (pharmacokinetics) and whether there are any safety signals from taking them together. Healthy adults aged 18 to 55 with a BMI between 18 and 32, in good general health with normal heart and lab tests, are eligible, while those with a history of drug or alcohol abuse, hepatitis, HIV, tobacco use, uncontrolled high blood pressure, or significant mental health disorders are excluded. Participants will receive three different drug combinations in a crossover sequence over approximately 44 days, with blood samples taken to measure drug levels and safety monitored throughout. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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