Schizophrenia
Conditions
Keywords
Mental Health Conditions, Schizophrenia
Brief 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.
Interventions
DRUG14C-SEP-380135
Oral Capsule
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²). 2. In good overall health, based on: 1. Medical history 2. Physical examination 3. Neurological examination 4. Vital signs 5. Electrocardiogram (ECG) 6. Blood and urine tests (serum chemistry, hematology, urinalysis, serology) 3. Regular daily bowel movements (at least one per day) for 30 days before Day -2. 4. Ability to provide written informed consent and follow all study instructions. 5. Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.
Exclusion criteria
1. Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening. 2. Have had prior exposure to SEP-380135. 3. Are currently participating in another clinical trial. 4. Attempted suicide within 12 months prior to screening. 5. 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. 6. Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Time for Cmax (tmax) of SEP-380135 and Metabolites | Up to 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 |
| Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites | Up to Day 8 |
| Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites | 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 |
Countries
United States
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed