DS-7830A PHASE 1 STUDY-A study to assess the safety,tolerability, and pharmacokinetics of single and multiple oral administration of DS-7830a in Japanese healthy adults, and to evaluate the effect of food (high-fat and low-fat meal) on the pharmacokinetics of orally administrated DS-7830a in Japanese healthy adults-

JRCT ID: jRCT2051230152

Registered date:22/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: major depressive disorder
• Date of first enrollment: 26/12/2023
• Target sample size: 64
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

Primary Outcome

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 Outcome

Safety: AEs, laboratory data, body weight, vital signs, standard 12-lead ECG, and C-SSRS.
Pharmacodynamics: Choice Reaction Time (CRT) task

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Inoguchi Akihiro