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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-

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-

Inoguchi Akihiro

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

Contact for Clinical Trial Information

Daiichi Sankyo Co., Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

Complete

Dec. 26, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 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

Both

major depressive disorder

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.

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

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

+81-6-6395-9000

Dec. 21, 2023

No

None