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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centanafadine | Drug | Centanafadine will be administered as an oral capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Centanafadine | Up to Day 5 | |
| Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine | Up to Day 5 | |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine | Up to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) of Centanafadine | Up to Day 5 | |
| Percentage (%) of Extrapolated AUC of Centanafadine | Up to Day 5 | |
| Terminal Phase Elimination Half-life (t1/2,z) of Centanafadine |
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Inclusion Criteria
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.
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc | Lenexa | Kansas | 66219 | United States |
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.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Up to Day 5 |
| Apparent Clearance from Plasma (CL/F) After Extravascular Administration of Centanafadine | Up to Day 5 |