Dravet syndrome, Lennox-Gastaut syndrome
Conditions
Interventions
Subjects are orally treated with DSP-0378 (4.8-360 mg) or Placebo.
Sponsors
Tsukada Hironobu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult male subject between 20 and 50 years of age (inclusive) at time of informed consent. 2. Subject's body weight is between 50.0 kg and 80.0 kg, and body mass index (BMI) is at least 18 kg/m2 but no more than 25 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Subject with a history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, neurologic disease, and who considered ineligible for the study by the Principal Investigator or Sub-Investigator. 2. Subject who has a presence or history of any medically diagnosed psychiatric disorder (including intellectual disability and substance-related disorders). 3. Subject who answers ''yes'' to ''Suicidal Ideation'' Items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at clinic admission. 4. Subject with a history of substance abuse, drug abuse, or a positive urine drug screening at screening visit or clinic admission. 5. Subject who has clinical symptoms suggestive of infection with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), or has a positive SARS-CoV-2 nucleic acid amplification test at clinic admission. 6. Subject who has received a vaccine within 7 days prior to screening visit or clinic admission. 7. Subject who is in the opinion of the Principal Investigator or Sub-Investigator, unsuitable in any other way to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Adverse events, clinical laboratory tests, vital signs, body weight, ECG, C-SSRS, neurological, RASS Pharmacokinetic Endpoints: Pharmacokinetics parameters Pharmacodynamic endpoint: Electroencephalogram | — |
Contacts
Public ContactProduct information center
Sumitomo Pharma Co., Ltd.
Outcome results
None listed