A Single Ascending Dose Study of DSP-0378 in Healthy Japanese Adult Male Subjects

JRCT ID: jRCT2071220068

Registered date:07/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dravet syndrome, Lennox-Gastaut syndrome
• Date of first enrollment: 14/11/2022
• Target sample size: 88
• Study type: Interventional
• Intervention(s): Subjects are orally treated with DSP-0378 (4.8-360 mg) or Placebo.

Outcome(s)

Primary Outcome

Safety Endpoints: Adverse events, clinical laboratory tests, vital signs, body weight, ECG, C-SSRS, neurological, RASS
Pharmacokinetic Endpoints: Pharmacokinetics parameters
Pharmacodynamic endpoint: Electroencephalogram

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ishikawa Tatsuya