Healthy Adult ParticipantsPhase 1NCT07486895
Trial to Demonstrate the Equivalence of Two Different Strengths of Oral Centanafadine Capsules in Healthy Subjects
A Phase 1 study testing Centanafadine in people with Healthy Adult Participants, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Centanafadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 18 May 2023
- 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 principal 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 investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- History of drug and/or alcohol abuse within 2 years prior to screening.
- History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- Participants having taken an investigational drug within 30 days prior to screening.
- Previous exposure to centanafadine.
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- Any history of significant bleeding or hemorrhagic tendencies.
- A history of difficulty in donating blood.
- The donation of blood or plasma within 30 days prior to the first dose of investigational medical product (IMP).
- Use of prescription, over-the-counter, herbal medication or vitamin supplements within 14 days prior to the first dose of IMP and antibiotics within 30 days prior to the first dose of IMP.
- 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
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Crossover Trial in Healthy Subjects to Assess Dose Strength Equivalence Among 164.4 and 328.8 mg Strengths of Oral Centanafadine QD XR Capsules
The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.
- Conditions
- Healthy Adult Participants
- Being tested
- Centanafadine
- Keywords
- ADHD, Attention-deficit/hyperactivity disorder
- 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
Centanafadine will be administered as an oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR | Experimental | Participants will first receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 1, followed by 2 × 164.4 mg centanafadine QD XR capsules administered orally once daily on Day 5. Receives: Drug: Centanafadine |
| CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR | Experimental | Participants will first receive 2 × 164.4 mg centanafadine QD XR capsule, orally on Day 1. Then, they will receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 5. Receives: Drug: Centanafadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Centanafadine
Measured: Up to Day 5
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
Measured: Up to Day 5
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
Measured: Up to Day 5
Secondary outcomes (4)
Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine
Measured: Up to Day 5
Percentage (%) of Extrapolated AUC of Centanafadine
Measured: Up to Day 5
Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine
Measured: Up to Day 5
Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine
Measured: Up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start8 Mar 2023
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486895
- Sponsor's protocol ID
- 405-201-00102
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Trial in Healthy Subjects to Assess Dose Strength Equivalence Among 164.4 and 328.8 mg Strengths of Oral Centanafadine QD XR Capsules
- ClinicalTrials.gov ID
- NCT07486895
- Acronym / sponsor ID
- 405-201-00102
- Conditions
- Healthy Adult Participants
- Keywords
- ADHD, Attention-deficit/hyperactivity disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 23 Mar 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.
The purpose of this study is to demonstrate dose strength equivalence of 2 × 164.4 milligrams (mg) centanafadine (CTN) once daily (QD) extended-release (XR) capsules to a 1 × 328.8 mg centanafadine QD XR capsule in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR | Experimental | Drug: CentanafadineParticipants will first receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 1, followed by 2 × 164.4 mg centanafadine QD XR capsules administered orally once daily on Day 5. |
| CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR | Experimental | Drug: CentanafadineParticipants will first receive 2 × 164.4 mg centanafadine QD XR capsule, orally on Day 1. Then, they will receive 1 × 328.8 mg centanafadine QD XR capsule orally on Day 5. |
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 principal investigator, to comply with all the requirements of the trial.
Key exclusion criteria (11 listed)
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigators or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
- History of drug and/or alcohol abuse within 2 years prior to screening.
- History of or current hepatitis or acquired immunodeficiency syndrome (AIDS) or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- Participants having taken an investigational drug within 30 days prior to screening.
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 |
|---|---|---|
| CentanafadineCentanafadine will be administered as an oral capsule. | Drug | CTN 1 x 328.8 mg QD XR, Then CTN 2 x 164.4 mg QD XR, CTN 2 x 164.4 mg QD XR, Then CTN 1 x 328.8 mg QD XR |
Primary outcome
Maximum Plasma Concentration (Cmax) of Centanafadine
Time frame: Up to Day 5
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
Time frame: Up to Day 5
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
Time frame: Up to Day 5
4 secondary outcomes
Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine
Time frame: Up to Day 5
Percentage (%) of Extrapolated AUC of Centanafadine
Time frame: Up to Day 5
Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine
Time frame: Up to Day 5
Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine
Time frame: Up to Day 5
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 23 Mar 2026.
- 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 in people with Healthy Adult Participants, 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 7 inclusion and 11 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 23 Mar 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?
Maximum Plasma Concentration (Cmax) of Centanafadine (time frame: Up to Day 5). The study lists 3 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 23 Mar 2026.