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 Akihiro0 个研究点目标入组 64 人开始时间: 2023年12月22日最近更新: 2024年5月27日

适应症

试验速览

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•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.

发起方

Inoguchi Akihiro