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The purpose of this trial is to assess relative bioavailability of centanafadine (CTN) SR tablet to CTN QD XR capsule in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
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| Arm 3: CTN 328.8 mg QD XR Fasted, Then CTN 328.8 mg QD XR Fed | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centanafadine SR | Drug | Oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of Centanafadine | Up to Day 6 | |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of Centanafadine | Up to Day 6 | |
| Maximum Plasma Concentration (Cmax) of Centanafadine | Up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of Centanafadine | Up to Day 6 | |
| Terminal-phase Eimination Half-life (T1/2z) of Centanafadine | Up to Day 6 | |
| Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) of Centanafadine |
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Inclusion Criteria:
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.
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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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.
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| 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. |
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| Centanafadine QD XR | Drug | Oral capsules. |
|
|
| Up to Day 6 |
| AUCt of Centanafadine Under Fasted and Fed Conditions | Up to Day 6 |
| AUCinfinity of Centanafadine Under Fasted and Fed Conditions | Up to Day 6 |
| Cmax of Centanafadine Under Fasted and Fed Conditions | Up to Day 6 |
| ID | Term |
|---|---|
| C574080 | 1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane |
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