major depression
Conditions
Interventions
Single oral doses of MSP-2020 tablets or placebo tablets will be administered. The dose will be increased incrementally , proceeding to each subsequent dose after the safety, tolerability, and pharmac
Sponsors
Tsunoda Takeshi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Body mass index (BMI) between 18.5 kg/m2and 30.0 kg/m2 2)Participants who weigh 70 kg or more 3)Participant who can provide a consent form signed by themselves prior to the start of any procedure related to the clinical trial and who, in the judgment of the principal investigator or subinvestigator, are able to comply with all requirements of this clinical trial.
Exclusion criteria
Exclusion criteria: 1)Participant who has been determined by the investigator or subinvestigator to have a clinically significant abnormality that may endanger the subject or affect drug absorption, distribution, metabolism, excretion, and endpoints. This includes, but is not limited to, a history of or complications from cardiovascular disease [e.g., valvular disease, cardiac circulatory disease, pulmonary hypertension, and prolonged QT syndrome (including family history)], hepatic disease, renal disease, neurological disease, endocrine disease, gastrointestinal disease, respiratory disease, hematologic disease (including significant bleeding or bleeding tendency), immune disorders but not limited to. 2)Participant who falls under any of the following conditions. However, if the investigator or subinvestigator determines that there is no clinical problem, the patient shall be re-measured after an interval of at least 10 minutes, and if two consecutive times or two out of three times do not fall within the range set in the exclusion criteria, the patient shall not violate the exclusion criteria. -Participant has a systolic blood pressure outside the range of 90-140 mmHg or a diastolic blood pressure outside the range of 50-90 mmHg in the supine, semi supine, or standing position. Blood pressure drop due to standing is more than 20 mmHg in the supine systolic pressure-or more than 10 mmHg in the supine diastolic pressure. -Participant has a pulse rate outside the range of 50-100 bpm when supine. Even if the re-measurement result is 40-49 bpm, if the investigator or subinvestigator determines that the subject is healthy and has no clinical problems, the subject shall not meet the exclusion criteria. 3)Participant with a history of epilepsy or other convulsive disorders such as epilepsy, excluding childhood febrile seizures and transient seizures in childhood, and clinically problematic head trauma. The patient's first-degree relative (the patient's parent) must have epilepsy (except for symptomatic epilepsy). Or those who have been judged by the investigator or subinvestigator to be at risk of seizures by participating in this study. 4)Participant with abnormal findings on screening EEG 5)Participant with a history of psychiatric disorders or comorbidities, including substance use disorders and neurodevelopmental disorders, based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [assessed by medical history and brief structured interview for psychiatric disorders (M.I.N.I.)]. 6)Participant has a first-degree relative (parents of the Participant) with a history of or complications from schizophrenia spectrum disorder, psychotic disorder, bipolar disorder, and related disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: -AEs -Vital signs (blood pressure, pulse, respiratory rate, temperature) -SpO2 -Clinical Laboratory (Hematology, Biochemistry, Coagulation, Urinalysis) -Physical and neurological findings -Echocardiogram -12-lead ECG -Holter electrocardiogram -C-SSRS -SDI -PANSS Positive Scale -Safety EEG -Pupil examination -Body weight Pharmacokinetic endpoints: -Plasma concentrations of MSP-2020 and metabolite product -Pharmacokinetic parameters of MSP-2020 and metabolite product | — |
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed