Healthy Adult Male Participants
Conditions
Interventions
A single oral dose of SEP-380135 or placebo will be administered under fasted conditions. The starting dose of SEP-380135 will be 6 mg, and then the dose will be gradually increased to 12 mg and 18 mg
Sponsors
Sanada Nobuhito
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese males at least 18 years but less than 40 years of age at the time of informed consent 2) Body mass index (BMI) of at least 18.5 kg/m2 but less than 25.0 kg/m2 at screening 3) Participants judged to be in good health based on medical history (current or past history) and physical examination, neurological examination, vital signs, ECG, and laboratory tests (hematology, biochemistry, and urinalysis) at screening and admission 4) Participants who are able to provide signed informed consent before the start of trial-related procedures, and are judged by the investigator or subinvestigator to meet all the requirements of this clinical trial
Exclusion criteria
Exclusion criteria: 1) Any clinically significant prior medical history or physical examination abnormality at screening or admission, which in the opinion of the investigator or subinvestigator may put the participant at risk or affect drug absorption, distribution, metabolism, excretion, and endpoints This includes, but is not limited to, prior or concurrent cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, respiratory, hematological, and immunological disease. 2) Current or past history of psychiatric or neurological disorders (including but not limited to epilepsy, stroke, multiple sclerosis, head injury with loss of consciousness, other neurological sequelae, loss of consciousness of any duration, intellectual or learning disorder, encephalopathy, major depression, anxiety, and psychosis) 3) A history of gastrointestinal surgery that may affect pharmacokinetics (excluding simple appendectomy performed 6 months or more before informed consent) 4) A prior or current history of hepatitis or acquired immunodeficiency syndrome, or a positive immunology test (hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antigen/antibody, syphilis) at screening 5) CYP2D6 or CYP2C19 phenotype determined to be PM or is indeterminable in the CYP genetic test at screening 6) The use of any other investigational product not approved in Japan within 120 days before investigational medicinal product (IMP) administration, or use of any other investigational product approved in Japan within 90 days before IMP administration 7) Any clinically significant 12-lead ECG finding at screening or admission. For example, HR > 100 bpm, HR 120 ms, QTcF interval > 450 ms, PR interval > 220 ms 8) Abnormal liver or renal function test values at screening and admission (For liver function, any of the following results are more than twice the upper limit of normal: aspartate aminotransferase, alanine aminotransferase, or total bilirubin. For renal function, estimated creatinine clearance based on serum creatinine is less than 60 mL/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints - Adverse events - Laboratory tests (hematology, biochemistry, and urinalysis) - Physical examination - Neurological examination - Vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) - Body weight - 12-Lead ECG - Holter ECG - Columbia Suicide Severity Rating Scale (C-SSRS) Pharmacokinetic endpoints - Plasma concentrations of SEP-380135 and 2 metabolites - Pharmacokinetic parameters of SEP-380135 and 2 metabolites | — |
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed