ADHDPhase 1NCT07314333
A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
A Phase 1 study testing Centanafadine, Methylphenidate and Lisdexamfetamine in people with ADHD, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Centanafadine, Methylphenidate and Lisdexamfetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 15 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- ADHD
- Being tested
- Centanafadine, Methylphenidate, Lisdexamfetamine
- Keywords
- Attention-deficit/hyperactivity disorder, Healthy Adults
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentanafadineDrug
Also called EB-1020
Oral, QD XR capsules.
MethylphenidateDrug
Also called Concerta
Oral tablets.
LisdexamfetamineDrug
Also called Vynase
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Sequence 1: ABC | Experimental | 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. Receives: Drug: Centanafadine; Drug: Methylphenidate |
| Arm 1, Sequence 2: BCA | Experimental | 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. Receives: Drug: Centanafadine; Drug: Methylphenidate |
| Arm 1, Sequence 3: CAB | Experimental | 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. Receives: Drug: Centanafadine; Drug: Methylphenidate |
| Arm 2, Sequence 1: ABC | Experimental | 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. Receives: Drug: Centanafadine; Drug: Lisdexamfetamine |
| Arm 2, Sequence 2: BCA | Experimental | 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. Receives: Drug: Centanafadine; Drug: Lisdexamfetamine |
| Arm 2, Sequence 3: CAB | Experimental | 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. Receives: Drug: Centanafadine; Drug: Lisdexamfetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
Measured: Baseline, Day 12 or ET
Change from Baseline in Heart Rate (HR) at Day 12 or ET
Measured: Baseline, Day 12 or ET
Secondary outcomes (7)
Maximal peak plasma concentration (Cmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
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
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Area under the concentration time curve from time zero to infinity (AUC-inf) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Time to maximum (peak) Plasma Concentration (Tmax) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Terminal phase elimination half-life (t1/2,z) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Volume of distribution following extravascular administration (Vz/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Apparent clearance of drug from plasma after extravascular administration (CL/F) for Centanafadine when co-administered with methylphenidate or lisdexamfetamine
Measured: Days 1, 5, and 9: pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start5 Feb 2026
- Primary completion30 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314333
- Sponsor's protocol ID
- 405-201-00198
- Status last verified
- Apr 2026
- First submitted
- 18 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07314333
- Acronym / sponsor ID
- 405-201-00198
- Conditions
- ADHD
- Keywords
- Attention-deficit/hyperactivity disorder, Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Sequence 1: ABC | Experimental | Drug: Centanafadine, Drug: MethylphenidateParticipants 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. |
| Arm 1, Sequence 2: BCA | Experimental | Drug: Centanafadine, Drug: MethylphenidateParticipants 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. |
| Arm 1, Sequence 3: CAB | Experimental | Drug: Centanafadine, Drug: MethylphenidateParticipants 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. |
| Arm 2, Sequence 1: ABC | Experimental | Drug: Centanafadine, Drug: LisdexamfetamineParticipants 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. |
| Arm 2, Sequence 2: BCA | Experimental | Drug: Centanafadine, Drug: LisdexamfetamineParticipants 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. |
| Arm 2, Sequence 3: CAB | Experimental | Drug: Centanafadine, Drug: LisdexamfetamineParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m2).
- Must be in good health, based on:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CentanafadineAlso: EB-1020Oral, QD XR capsules. | Drug | Arm 1, Sequence 1: ABC, Arm 1, Sequence 2: BCA, Arm 1, Sequence 3: CAB, Arm 2, Sequence 1: ABC, Arm 2, Sequence 2: BCA, Arm 2, Sequence 3: CAB |
| MethylphenidateAlso: ConcertaOral tablets. | Drug | Arm 1, Sequence 1: ABC, Arm 1, Sequence 2: BCA, Arm 1, Sequence 3: CAB |
| LisdexamfetamineAlso: VynaseOral capsules | Drug | Arm 2, Sequence 1: ABC, Arm 2, Sequence 2: BCA, Arm 2, Sequence 3: CAB |
Primary outcome
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET)
Time frame: Baseline, Day 12 or ET
Change from Baseline in Heart Rate (HR) at Day 12 or ET
Time frame: Baseline, Day 12 or ET
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Centanafadine, Methylphenidate and Lisdexamfetamine in people with ADHD, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Blood Pressure (BP) at Day 12 or Early Termination (ET) (time frame: Baseline, Day 12 or ET). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.