A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (NCT07314333) | Clinical Trial Compass
CompletedPhase 1
A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
United States40 participantsStarted 2026-02-05
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
What they're measuring
1
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
Timeframe: Baseline, Day 12 or ET
2
Change from Baseline in Heart Rate (HR) at Day 12 or ET
Timeframe: Baseline, Day 12 or ET
Trial details
NCT IDNCT07314333
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.