major depressive disorder
Conditions
Interventions
10 to 80 mg of DS-7830a or Placebo is administered at a single oral dose, or an appropriate dose of DS-7830a within the dose range as stated above or Placebo is administered at multiple oral doses.
Sponsors
Inoguchi Akihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Age: 18 to 45 years at the time of informed consent 3. Body mass index (BMI) at screening: >=18.5 and <25.0 kg/m^2
Exclusion criteria
Exclusion criteria: Exclusion criteria at screening 1. Having a history of a serious disease attributable to central nervous, psychiatric, cardiovascular, respiratory, blood and hematopoietic, or gastrointestinal system disorders, or other disorders including hepatic/renal impairment, thyroid dysfunction, pituitary malfunction, and adrenal insufficiency, and the conduct of the study is not appropriate for the safety of the subject as judged by the investigator or subinvestigator. 2. Having clinically significant symptoms (eg, headache, dizziness), findings (eg, blood pressure decreased), abnormalities on ECG, or deviations from the reference ranges for laboratory tests at the study site at screening as judged by the investigator or subinvestigator (however, the subject will not be excluded if the disease will not affect participation in the study as judged by the investigator or subinvestigator). 3. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy). 4. Having alcohol or drug dependence. 5. Having received or planning to receive treatment by other physicians during the period from 14 days before study drug administration to the post-study examination or the follow-up examination. etc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events (AEs), laboratory data, body weight, vital signs, standard 12-lead electrocardiogram(ECG), Holter ECG and Columbia-Suicide Severity Rating Scale (hereinafter referred to as C-SSRS). Pharmacokinetics: Pharmacokinetic parameters of plasma and urine DS-7830a concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: AEs, laboratory data, body weight, vital signs, standard 12-lead ECG, and C-SSRS. Pharmacodynamics: Choice Reaction Time (CRT) task | — |
Contacts
Public ContactContact for Clinical Trial Information
Daiichi Sankyo Co., Ltd.
Outcome results
None listed