A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
NCT ID: NCT07314333
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2026-02-03
2026-03-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1, Sequence 1: ABC
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.
Centanafadine
Oral, QD XR capsules.
Methylphenidate
Oral tablets.
Arm 1, Sequence 2: BCA
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.
Centanafadine
Oral, QD XR capsules.
Methylphenidate
Oral tablets.
Arm 1, Sequence 3: CAB
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.
Centanafadine
Oral, QD XR capsules.
Methylphenidate
Oral tablets.
Arm 2, Sequence 1: ABC
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.
Centanafadine
Oral, QD XR capsules.
Lisdexamfetamine
Oral capsules
Arm 2, Sequence 2: BCA
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.
Centanafadine
Oral, QD XR capsules.
Lisdexamfetamine
Oral capsules
Arm 2, Sequence 3: CAB
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.
Centanafadine
Oral, QD XR capsules.
Lisdexamfetamine
Oral capsules
Interventions
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Centanafadine
Oral, QD XR capsules.
Methylphenidate
Oral tablets.
Lisdexamfetamine
Oral capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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ICON
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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405-201-00198
Identifier Type: -
Identifier Source: org_study_id
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