A double-blind, placebo-controlled, clinical pharmacology study to investigate the safety, tolerability and pharmacokinetics of single and multiple doses of MT-5199 in healthy male Korean subjects

Mitsubishi Tanabe Pharma Korea0 个研究点目标入组 44 人开始时间: 待定最近更新: 2020年11月3日

试验速览

暂无简介。

•1.Healthy male Korean adult volunteers aged 20-45 years at the time of obtaining their informed consent
•2.Persons weighing 50 kg or more and with a body mass index (BMI) of within 18.0-25.0 at the time of the screening
•3.Persons who decided to participate voluntarily in this study and to provide their consent in writing before the screening test
•4.Persons eligible as subjects of this study based on the results of their physical examination, laboratory test, history taking, etc. at the discretion of the investigator

•1.Persons with a current disease history or a clinically significant treatment history for heart, liver, kidney, digestive system, respiratory system, nervous system, hematopoietic function, endocrine function, or mental illness
•2.Persons with a current or past history of gastrointestinal disorders and/or a past history of gastrointestinal surgery that may affect the safety and pharmacokinetics evaluation of the investigational product
•3.Persons with hypersensitivity or a history of clinically significant hypersensitivity to drugs containing valbenazine and other drugs
•4.Persons with a history of food allergy
•5.Persons with a history of substance or alcohol abuse or with positive results on substance abuse
•6.Persons with positive results for HBsAg, syphilis serum reaction, HCV antibody, or HIV antigen/antibody
•7.Persons with QTc interval >430 ms in the 12-lead ECG performed, or with other clinically suspected abnormal findings
•8.Persons with clinically significant test abnormalities found
•9.Persons determined by the investigator to have suicide risk
•10.Persons deemed as having depressive symptoms by the investigator

发起方

Mitsubishi Tanabe Pharma Korea