Healthy VolunteersPhase 1NCT07465731
A Trial to Compare the Amount of Centanafadine That Enters the Bloodstream for Two Different Formulations of Centanafadine
A Phase 1 study testing Centanafadine SR and Centanafadine QD XR in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN 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 Volunteers
- What is being tested?
- Centanafadine SR and Centanafadine QD XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2022to 26 Mar 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 from 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
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- 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.
- Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
- Any participant who, in the opinion of the investigator, should not participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-arm Trial to Assess Relative Bioavailability of Centanafadine Sustained-Release (SR) Tablet to Once-Daily Extended-Release (QD XR) Capsule Following Oral Administration in Healthy Adult Subjects
The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Centanafadine SR, Centanafadine QD XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centanafadine SRDrug
Also called EB-1020
Oral tablets.
Centanafadine QD XRDrug
Also called EB-1020
Oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR | Experimental | Participants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4. Receives: Drug: Centanafadine SR; Drug: Centanafadine QD XR |
| Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR | Experimental | Participants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4. Receives: Drug: Centanafadine SR; Drug: Centanafadine QD XR |
| Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR | Experimental | Participants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4. Receives: Drug: Centanafadine SR; Drug: Centanafadine QD XR |
| Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR | Experimental | Participants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4. Receives: Drug: Centanafadine SR; Drug: Centanafadine QD XR |
| Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed | Experimental | Participants receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fed state on Day 4. Receives: Drug: Centanafadine QD XR |
| Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted | Experimental | Participants receive CTN 328.8 mg, QD XR, capsule, orally in fed state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 4. Receives: Drug: Centanafadine QD XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
Measured: Up to Day 6
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
Measured: Up to Day 6
Maximum Plasma Concentration (Cmax) of Centanafadine
Measured: Up to Day 6
Secondary outcomes (6)
Time to Maximum Plasma Concentration (Tmax) of Centanafadine
Measured: Up to Day 6
Terminal-phase Eimination Half-life (T1/2z) of Centanafadine
Measured: Up to Day 6
Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine
Measured: Up to Day 6
AUCt of Centanafadine Under Fasted and Fed Conditions
Measured: Up to Day 6
AUCinfinity of Centanafadine Under Fasted and Fed Conditions
Measured: Up to Day 6
Cmax of Centanafadine Under Fasted and Fed Conditions
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start27 Oct 2022
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465731
- Sponsor's protocol ID
- 405-201-00018
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-arm Trial to Assess Relative Bioavailability of Centanafadine Sustained-Release (SR) Tablet to Once-Daily Extended-Release (QD XR) Capsule Following Oral Administration in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07465731
- Acronym / sponsor ID
- 405-201-00018
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 12 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 trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR | Experimental | Drug: Centanafadine SR, Drug: Centanafadine QD XRParticipants receive CTN 200 mg total daily dose (TDD) SR, tablet, orally on Day 1, then, they receive CTN 164.4 mg QD XR, capsule, orally on Day 4. |
| Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR | Experimental | Drug: Centanafadine SR, Drug: Centanafadine QD XRParticipants receive CTN 164.4 mg QD XR capsule, orally on Day 1, then, they receive CTN 200 mg TDD SR, tablet, orally on Day 4. |
| Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR | Experimental | Drug: Centanafadine SR, Drug: Centanafadine QD XRParticipants receive CTN 400 mg TDD SR, tablet, orally on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally on Day 4. |
| Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR | Experimental | Drug: Centanafadine SR, Drug: Centanafadine QD XRParticipants receive CTN 328.8 mg QD XR, capsule, orally on Day 1, then, they receive CTN 400 mg TDD SR, orally, on Day 4. |
| Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed | Experimental | Drug: Centanafadine QD XRParticipants receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fed state on Day 4. |
| Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted | Experimental | Drug: Centanafadine QD XRParticipants receive CTN 328.8 mg, QD XR, capsule, orally in fed state on Day 1, then, they receive CTN 328.8 mg QD XR, capsule, orally in fasted state on Day 4. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index from 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 (6 listed)
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
- 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.
- Consumption of alcohol and/or food and beverages containing caffeine, methylxanthines (e.g., coffee, chocolate) within 72 hours prior to dosing.
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or hepatitis C antibodies, or human immunodeficiency virus antibodies.
- History of any significant drug allergy or known or suspected hypersensitivity.
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 |
|---|---|---|
| Centanafadine SRAlso: EB-1020Oral tablets. | Drug | Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR, Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR, Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR, Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR |
| Centanafadine QD XRAlso: EB-1020Oral capsules. | Drug | Arm 1: CTN 164.4 mg QD XR, Then CTN 200 mg TDD SR, Arm 1: CTN 200 milligrams (mg) TDD SR, Then CTN 164.4 mg QD XR, Arm 2: CTN 328.8 mg QD XR, Then CTN 400 mg TDD SR, Arm 2: CTN 400 TDD mg SR, Then CTN 328.8 mg QD XR, Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed, Arm 3: CTN 328.8 mg QD XR Fed, Then CTN 328.8 mg QD XR Fasted |
Primary outcome
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine
Time frame: Up to Day 6
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine
Time frame: Up to Day 6
Maximum Plasma Concentration (Cmax) of Centanafadine
Time frame: Up to Day 6
6 secondary outcomes
Time to Maximum Plasma Concentration (Tmax) of Centanafadine
Time frame: Up to Day 6
Terminal-phase Eimination Half-life (T1/2z) of Centanafadine
Time frame: Up to Day 6
Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine
Time frame: Up to Day 6
AUCt of Centanafadine Under Fasted and Fed Conditions
Time frame: Up to Day 6
AUCinfinity of Centanafadine Under Fasted and Fed Conditions
Time frame: Up to Day 6
Cmax of Centanafadine Under Fasted and Fed Conditions
Time frame: Up to Day 6
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 12 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 SR and Centanafadine QD XR in people with Healthy Volunteers, 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 6 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 12 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?
Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine (time frame: Up to Day 6). 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 12 Mar 2026.