SchizophreniaPhase 1NCT07455084
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
A Phase 1 study testing 14C-SEP-380135 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- 14C-SEP-380135
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 2 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
- In good overall health, based on:
- Medical history
- Physical examination
- Neurological examination
- Vital signs
Show all 11Show fewer
- Electrocardiogram (ECG)
- Blood and urine tests (serum chemistry, hematology, urinalysis, serology)
- 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.
Who cannot join
- Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
- Have had prior exposure to SEP-380135.
- Are currently participating in another clinical trial.
- Attempted suicide within 12 months prior to screening.
- A history of sick sinus syndrome, any degree of atrioventricular block, Heart attack (myocardial infarction), heart failure (NYHA Class II-IV), cardiomyopathy, pulmonary congestion, cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.
- Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults
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.
- Conditions
- Schizophrenia
- Being tested
- 14C-SEP-380135
- Keywords
- Mental Health Conditions, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-SEP-380135Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| 14C-SEP-380135 | Experimental | Participants receive a single oral administration of 14C-SEP-380135 on Day 1. Receives: Drug: 14C-SEP-380135 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Radioactivity Amount Excreted in Urine (Ae,u)
Measured: Up to Day 8
Total Radioactivity Amount Excreted in Feces (Ae,f)
Measured: Up to Day 8
Fraction of Dose Excreted in Urine (%fe,u)
Measured: Up to Day 8
Fraction of Dose Excreted in Feces (%fe,f)
Measured: Up to Day 8
Secondary outcomes (14)
Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites
Measured: Up to Day 8
Time for Cmax (tmax) of SEP-380135 and Metabolites
Measured: 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
Measured: Up to Day 8
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites
Measured: Up to Day 8
Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites
Measured: Up to Day 8
Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135
Measured: Up to Day 8
Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135
Measured: Up to Day 8
Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135
Measured: Up to Day 8
Number of Participants with Adverse Events (AEs)
Measured: Up to Day 31
Number of Participants with Potentially Clinically Significant Changes in Vital Signs
Measured: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Measured: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
Measured: Upto Day 8
Number of Participants With Incidence of Suicidal Ideation and Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Upto Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion2 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455084
- Sponsor's protocol ID
- 384-201-00003
- Status last verified
- Oct 2026
- First submitted
- 3 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT07455084
- Acronym / sponsor ID
- 384-201-00003
- Conditions
- Schizophrenia
- Keywords
- Mental Health Conditions, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 6 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-SEP-380135 | Experimental | Drug: 14C-SEP-380135Participants receive a single oral administration of 14C-SEP-380135 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
- Have had prior exposure to SEP-380135.
- Are currently participating in another clinical trial.
- Attempted suicide within 12 months prior to screening.
- A history of sick sinus syndrome, any degree of atrioventricular block, Heart attack (myocardial infarction), heart failure (NYHA Class II-IV), cardiomyopathy, pulmonary congestion, cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.
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 |
|---|---|---|
| 14C-SEP-380135Oral Capsule | Drug | 14C-SEP-380135 |
Primary outcome
Total Radioactivity Amount Excreted in Urine (Ae,u)
Time frame: Up to Day 8
Total Radioactivity Amount Excreted in Feces (Ae,f)
Time frame: Up to Day 8
Fraction of Dose Excreted in Urine (%fe,u)
Time frame: Up to Day 8
Fraction of Dose Excreted in Feces (%fe,f)
Time frame: Up to Day 8
14 secondary outcomes
Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Time for Cmax (tmax) of SEP-380135 and Metabolites
Time frame: 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
Time frame: Up to Day 8
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites
Time frame: Up to Day 8
Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135
Time frame: Up to Day 8
Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135
Time frame: Up to Day 8
Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135
Time frame: Up to Day 8
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 31
Number of Participants with Potentially Clinically Significant Changes in Vital Signs
Time frame: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
Time frame: Upto Day 8
Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
Time frame: Upto Day 8
Number of Participants With Incidence of Suicidal Ideation and Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Upto Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Otsuka Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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 14C-SEP-380135 in people with Schizophrenia, 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 11 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: opening soon, as of the sponsor's last update on 16 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (844-687-8522, Otsuka-ProfessionalServices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Radioactivity Amount Excreted in Urine (Ae,u) (time frame: Up to Day 8). The study lists 4 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 16 Oct 2026.