Attention Deficit Disorder With HyperactivityPhase 1NCT07253441
A Trial to Characterize Differences in Blood Levels of Different Lots of Centanafadine QD XR and to Understand the Effect of Food on Blood Levels
A Phase 1 study testing CTN XR (TBM), CTN SR and CTN XR (Clin) in people with Attention Deficit Disorder With Hyperactivity, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- CTN XR (TBM), CTN SR and CTN XR (Clin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Aug 2024to 30 Dec 2024
- 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 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
- In good health as determined by:
- Medical history
- Physical examination
- Electrocardiogram (ECG)
- Serum/urine chemistry, hematology, and serology tests.
- Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the investigator, to comply with all the requirements of the trial.
Who cannot join
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
- History of drug and/or alcohol abuse within 2 years prior to screening.
- History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site.
- Any participant who, in the opinion of the investigator, should not participate in the trial.
- Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ICON Lenexa
Lenexa, Kansas, 66219
ICON Salt Lake City
Millcreek, Utah, 84124
About this study
Official title: A Multiple-arm, Phase 1, Open-label Trial to Determine Dose Strength Equivalence and Effect of Food on To-Be-Marketed Centanafadine QD XR Capsules, Bioequivalence Between Clinical and To-Be-Marketed QD XR Capsules and Relative Bioavailability of To-Be-Marketed QD XR Capsules to SR Tablets in Healthy Adults
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.
- Being tested
- CTN XR (TBM), CTN SR, CTN XR (Clin)
- Keywords
- Healthy Volunteers
- 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.
CTN XR (TBM)Drug
Also called EB-1020
Oral capsules
CTN SRDrug
Also called EB-1020
Oral tablets
CTN XR (Clin)Drug
Also called EB-1020
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsules | Experimental | Participants first receive a 1 × 328.8 mg CTN capsule, orally, on Day 1. Then, they receive 2 × 164.4 mg CTN capsules, orally, on Day 4. Receives: Drug: CTN XR (TBM) |
| Cohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsules | Experimental | Participants first receive 2 × 164.4 mg CTN capsules, orally, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, on Day 4. Receives: Drug: CTN XR (TBM) |
| Cohort 2: CTN Fasted State, Then CTN Fed state | Experimental | Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fasted state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fed state, on Day 4. Receives: Drug: CTN XR (TBM) |
| Cohort 2: CTN Fed state, Then CTN Fasted state | Experimental | Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fed state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fasted state, on Day 4. Receives: Drug: CTN XR (TBM) |
| Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR | Experimental | Participants first receive CTN 200 mg SR, tablets, orally on Day 1 followed by CTN 164.4 mg XR, capsules, orally on Day 4. Participants then receive CTN 400 mg SR, tablets, orally on Day 7, followed by CTN 328.8 mg XR, capsules, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN SR |
| Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR | Experimental | Participants first receive CTN 164.4 mg XR, capsules, orally on Day 1 followed by CTN 200 mg SR, tablets, orally on Day 4. Participants then receive CTN 328.8 mg XR, capsules, orally on Day 7, followed by CTN 400 mg SR, tablets, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN SR |
| Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR | Experimental | Participants first receive CTN 400 mg SR, tablets, orally on Day 1 followed by CTN 328.8 mg XR, capsules, orally on Day 4. Participants then receive CTN 200 mg SR, tablets, orally on Day 7, followed by CTN 164.4 mg XR, capsules, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN SR |
| Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR | Experimental | Participants first receive CTN 328.8 mg XR, capsules, orally on Day 1 followed by CTN 400 mg SR, tablets, orally on Day 4. Participants then receive CTN 164.4 mg XR, capsules, orally on Day 7, followed by CTN 200 mg SR, tablets, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN SR |
| Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM) | Experimental | Participants first receive CTN 164.4 mg XR (Clin), capsules, orally on Day 1 followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (Clin), capsules, orally on Day 7, followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN XR (Clin) |
| Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin) | Experimental | Participants first receive CTN 164.4 mg XR (TBM), capsules, orally on Day 1 followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (TBM), capsules, orally on Day 7, followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN XR (Clin) |
| Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM) | Experimental | Participants first receive CTN 328.8 mg XR (Clin), capsules, orally on Day 1 followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (Clin), capsules, orally on Day 7, followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN XR (Clin) |
| Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin) | Experimental | Participants first receive CTN 328.8 mg XR (TBM), capsules, orally on Day 1 followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (TBM), capsules, orally on Day 7, followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN XR (Clin) |
| Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR | Experimental | Participants first receive CTN 328.8 mg XR (TBM), capsules, orally, once a day (QD) from Day 1 to Day 5. Then, they receive CTN 400 mg SR, tablets, orally, from Day 6 to Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN SR |
| Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM) | Experimental | Participants first receive CTN 400 mg SR, tablets, orally from Day 1 to Day 5. Then, they will receive CTN 328.8 mg XR (TBM), capsules, orally, QD from Day 6 to Day 10. Receives: Drug: CTN XR (TBM); Drug: CTN SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve Calculated From Time 0 to Time t (AUCt) of CTN
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of CTN
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 5: Cmax of CTN
Measured: Up to Day 11
Cohort 5: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady-state of CTN XR
Measured: Up to Day 11
Cohort 5: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of CTN SR
Measured: 24 Hours postdose up to Day 10
Cohort 5: Minimum Plasma Concentration During a Dosing Interval (Cmin) of CTN
Measured: Up to Day 11
Secondary outcomes (13)
Cohorts 1, 2, 3, and 4: Percentage (%) Extrapolated AUC of CTN and its Metabolites
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohorts 1, 2, 3, and 4: AUC0-24h of CTN and its Metabolites
Measured: Cohorts 1 and 2: 24 Hours Postdose up to Day 4; Cohorts 3 and 4: 24 Hours Postdose up to Day 10
Cohort 1, 2, 3, and 4: Time to Maximum (peak) Plasma Concentration (tmax) of CTN and its Metabolites
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 1, 2, 3, and 4: Apparent Clearance (CL/F) of CTN and its Metabolites
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 1, 2, 3, and 4: Volume of Distribution (Vz/F) of CTN
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 1, 2, 3, and 4: Terminal Phase Elimination Half-Life (t1/2,z) of CTN and its Metabolites
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 5: Tmax of CTN and its Metabolites
Measured: Up to Day 11
Cohort 5: CL/F of CTN
Measured: Up to Day 11
All Cohorts: Number of Participants With Adverse Events (AEs)
Measured: Cohorts 1 and 2: Up to Day 11; Cohorts 3, 4, and 5: Up to Day 17
All Cohorts: Number of Participants With Potentially Clinically Relevant Laboratory Tests
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
All Cohorts: Number of Participants With Potentially Clinically Relevant Vital Signs
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
All Cohorts: Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Tests
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start29 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253441
- Sponsor's protocol ID
- 405-201-00157
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-arm, Phase 1, Open-label Trial to Determine Dose Strength Equivalence and Effect of Food on To-Be-Marketed Centanafadine QD XR Capsules, Bioequivalence Between Clinical and To-Be-Marketed QD XR Capsules and Relative Bioavailability of To-Be-Marketed QD XR Capsules to SR Tablets in Healthy Adults
- ClinicalTrials.gov ID
- NCT07253441
- Acronym / sponsor ID
- 405-201-00157
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 28 Nov 2025 (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.
The purpose of this study is to evaluate the dose strength equivalence of to-be-marketed (TBM) centanafadine (CTN) once daily (QD) extended release (XR) when administered as 2 capsules of 164.4 milligrams (mg) or as a single capsule of 328.8 mg, effect of food on the absorption of the TBM CTN QD XR capsule, and relative bioavailability of clinical (Clin) CTN sustained release (SR) tablets to the TBM CTN QD XR capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsules | Experimental | Drug: CTN XR (TBM)Participants first receive a 1 × 328.8 mg CTN capsule, orally, on Day 1. Then, they receive 2 × 164.4 mg CTN capsules, orally, on Day 4. |
| Cohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsules | Experimental | Drug: CTN XR (TBM)Participants first receive 2 × 164.4 mg CTN capsules, orally, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, on Day 4. |
| Cohort 2: CTN Fasted State, Then CTN Fed state | Experimental | Drug: CTN XR (TBM)Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fasted state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fed state, on Day 4. |
| Cohort 2: CTN Fed state, Then CTN Fasted state | Experimental | Drug: CTN XR (TBM)Participants first receive 1 × 328.8 mg CTN capsules, orally, in the fed state, on Day 1. Then, they receive 1 × 328.8 mg CTN capsule, orally, in the fasted state, on Day 4. |
| Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR | Experimental | Drug: CTN XR (TBM), Drug: CTN SRParticipants first receive CTN 200 mg SR, tablets, orally on Day 1 followed by CTN 164.4 mg XR, capsules, orally on Day 4. Participants then receive CTN 400 mg SR, tablets, orally on Day 7, followed by CTN 328.8 mg XR, capsules, orally on Day 10. |
| Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR | Experimental | Drug: CTN XR (TBM), Drug: CTN SRParticipants first receive CTN 164.4 mg XR, capsules, orally on Day 1 followed by CTN 200 mg SR, tablets, orally on Day 4. Participants then receive CTN 328.8 mg XR, capsules, orally on Day 7, followed by CTN 400 mg SR, tablets, orally on Day 10. |
| Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR | Experimental | Drug: CTN XR (TBM), Drug: CTN SRParticipants first receive CTN 400 mg SR, tablets, orally on Day 1 followed by CTN 328.8 mg XR, capsules, orally on Day 4. Participants then receive CTN 200 mg SR, tablets, orally on Day 7, followed by CTN 164.4 mg XR, capsules, orally on Day 10. |
| Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR | Experimental | Drug: CTN XR (TBM), Drug: CTN SRParticipants first receive CTN 328.8 mg XR, capsules, orally on Day 1 followed by CTN 400 mg SR, tablets, orally on Day 4. Participants then receive CTN 164.4 mg XR, capsules, orally on Day 7, followed by CTN 200 mg SR, tablets, orally on Day 10. |
| Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM) | Experimental | Drug: CTN XR (TBM), Drug: CTN XR (Clin)Participants first receive CTN 164.4 mg XR (Clin), capsules, orally on Day 1 followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (Clin), capsules, orally on Day 7, followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 10. |
| Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin) | Experimental | Drug: CTN XR (TBM), Drug: CTN XR (Clin)Participants first receive CTN 164.4 mg XR (TBM), capsules, orally on Day 1 followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 328.8 mg XR (TBM), capsules, orally on Day 7, followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 10. |
| Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM) | Experimental | Drug: CTN XR (TBM), Drug: CTN XR (Clin)Participants first receive CTN 328.8 mg XR (Clin), capsules, orally on Day 1 followed by CTN 328.8 mg XR (TBM), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (Clin), capsules, orally on Day 7, followed by CTN 164.4 mg XR (TBM), capsules, orally on Day 10. |
| Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin) | Experimental | Drug: CTN XR (TBM), Drug: CTN XR (Clin)Participants first receive CTN 328.8 mg XR (TBM), capsules, orally on Day 1 followed by CTN 328.8 mg XR (Clin), capsules, orally on Day 4. Participants then receive CTN 164.4 mg XR (TBM), capsules, orally on Day 7, followed by CTN 164.4 mg XR (Clin), capsules, orally on Day 10. |
| Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR | Experimental | Drug: CTN XR (TBM), Drug: CTN SRParticipants first receive CTN 328.8 mg XR (TBM), capsules, orally, once a day (QD) from Day 1 to Day 5. Then, they receive CTN 400 mg SR, tablets, orally, from Day 6 to Day 10. |
| Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM) | Experimental | Drug: CTN XR (TBM), Drug: CTN SRParticipants first receive CTN 400 mg SR, tablets, orally from Day 1 to Day 5. Then, they will receive CTN 328.8 mg XR (TBM), capsules, orally, QD from Day 6 to Day 10. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
- In good health as determined by:
- Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the investigator, to comply with all the requirements of the trial.
Key exclusion criteria (7 listed)
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
- History of drug and/or alcohol abuse within 2 years prior to screening.
- History of or current hepatitis or AIDS or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or HIV antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- A positive urine or breath alcohol test and/or urine drug screen for substance of abuse at screening or upon admission to the trial site.
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 |
|---|---|---|
| CTN XR (TBM)Also: EB-1020Oral capsules | Drug | Cohort 1: CTN 1 × 328.8 mg capsule, Then CTN 2 × 164.4 mg capsules, Cohort 1: CTN 2 × 164.4 mg capsule, Then CTN 1 × 328.8 mg capsules, Cohort 2: CTN Fasted State, Then CTN Fed state, Cohort 2: CTN Fed state, Then CTN Fasted state, Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR, Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR, Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR, Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR, Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM), Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin), Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM), Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin), Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR, Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM) |
| CTN SRAlso: EB-1020Oral tablets | Drug | Cohort 3: CTN 164.4 mg XR, Then CTN 200 mg SR, Then CTN 328.8 mg XR, Then CTN 400 mg SR, Cohort 3: CTN 200 mg SR, Then CTN164.4 mg XR, Then CTN 400 mg SR, Then CTN 328.8 mg XR, Cohort 3: CTN 328.8 mg XR, Then CTN 400 mg SR, Then CTN 164.4 mg XR, Then CTN 200 mg SR, Cohort 3: CTN 400 mg SR, Then CTN 328.8 mg XR, Then CTN 200 mg SR, Then CTN 164.4 mg XR, Cohort 5: CTN 328.8 mg XR (TBM), Then CTN 400 mg SR, Cohort 5: CTN 400 mg SR, Then CTN 328.8 mg XR (TBM) |
| CTN XR (Clin)Also: EB-1020Oral capsules | Drug | Cohort 4: CTN 164.4mg (Clin), Then CTN 164.4mg (TBM), Then CTN 328.8mg (Clin) Then CTN 328.8mg (TBM), Cohort 4: CTN 164.4mg (TBM), Then CTN 164.4mg (Clin), Then CTN 328.8mg (TBM) Then CTN 328.8mg (Clin), Cohort 4: CTN 328.8mg (Clin), Then CTN 328.8mg (TBM), Then CTN 164.4mg (Clin),Then CTN 164.4mg (TBM), Cohort 4: CTN 328.8mg (TBM), Then CTN 328.8mg (Clin), Then CTN 164.4mg (TBM) Then CTN 164.4mg (Clin) |
Primary outcome
Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve Calculated From Time 0 to Time t (AUCt) of CTN
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohorts 1, 2, 3, and 4: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of CTN
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 5: Cmax of CTN
Time frame: Up to Day 11
Cohort 5: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady-state of CTN XR
Time frame: Up to Day 11
Cohort 5: Area Under the Drug Concentration-time Curve From Time Zero Predose to 24 hours Postdose (AUC0-24h) of CTN SR
Time frame: 24 Hours postdose up to Day 10
Cohort 5: Minimum Plasma Concentration During a Dosing Interval (Cmin) of CTN
Time frame: Up to Day 11
13 secondary outcomes
Cohorts 1, 2, 3, and 4: Percentage (%) Extrapolated AUC of CTN and its Metabolites
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohorts 1, 2, 3, and 4: AUC0-24h of CTN and its Metabolites
Time frame: Cohorts 1 and 2: 24 Hours Postdose up to Day 4; Cohorts 3 and 4: 24 Hours Postdose up to Day 10
Cohort 1, 2, 3, and 4: Time to Maximum (peak) Plasma Concentration (tmax) of CTN and its Metabolites
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 1, 2, 3, and 4: Apparent Clearance (CL/F) of CTN and its Metabolites
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 1, 2, 3, and 4: Volume of Distribution (Vz/F) of CTN
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 1, 2, 3, and 4: Terminal Phase Elimination Half-Life (t1/2,z) of CTN and its Metabolites
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12
Cohort 5: Tmax of CTN and its Metabolites
Time frame: Up to Day 11
Cohort 5: CL/F of CTN
Time frame: Up to Day 11
All Cohorts: Number of Participants With Adverse Events (AEs)
Time frame: Cohorts 1 and 2: Up to Day 11; Cohorts 3, 4, and 5: Up to Day 17
All Cohorts: Number of Participants With Potentially Clinically Relevant Laboratory Tests
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
All Cohorts: Number of Participants With Potentially Clinically Relevant Vital Signs
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
All Cohorts: Number of Participants With Potentially Clinically Relevant 12-Lead Electrocardiogram (ECG) Tests
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
All Cohorts: Percentage of Participants With Suicidal Ideation or Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12; Cohort 5: Up to Day 11
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 11 Dec 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTN XR (TBM), CTN SR and CTN XR (Clin) in people with Attention Deficit Disorder With Hyperactivity, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites 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 7 inclusion and 7 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 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cohorts 1, 2, 3, and 4: Maximum Plasma Concentration (Cmax) of CTN (time frame: Cohorts 1 and 2: Up to Day 6; Cohorts 3 and 4: Up to Day 12). The study lists 7 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 11 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.