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The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-SEP-380135 | Experimental | Participants receive a single oral administration of 14C-SEP-380135 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-SEP-380135 | Drug | Oral Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Radioactivity Amount Excreted in Urine (Ae,u) | Up to Day 8 | |
| Total Radioactivity Amount Excreted in Feces (Ae,f) | Up to Day 8 | |
| Fraction of Dose Excreted in Urine (%fe,u) | Up to Day 8 | |
| Fraction of Dose Excreted in Feces (%fe,f) | Up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites | Up to Day 8 | |
| Time for Cmax (tmax) of SEP-380135 and Metabolites | Up to Day 8 | |
| Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites |
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Inclusion Criteria:
Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
In good overall health, based on:
Regular daily bowel movements (at least one per day) for 30 days before Day -2.
Ability to provide written informed consent and follow all study instructions.
Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Otsuka Call Center | Contact | 844-687-8522 | Otsuka-ProfessionalServices@otsuka-us.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Otsuka Clinical Trials website | View source |
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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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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Up to Day 8 |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites | Up to Day 8 |
| Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites | Up to Day 8 |
| Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135 | Up to Day 8 |
| Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135 | Up to Day 8 |
| Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135 | Up to Day 8 |
| Number of Participants with Adverse Events (AEs) | Up to Day 31 |
| Number of Participants with Potentially Clinically Significant Changes in Vital Signs | Upto Day 8 |
| Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Upto Day 8 |
| Number of Participants With Potentially Clinically Significant Changes in Physical Examinations | Upto Day 8 |
| Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters | Upto Day 8 |
| Number of Participants With Incidence of Suicidal Ideation and Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Upto Day 8 |