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
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004667
- Lead Sponsor
- Mitsubishi Tanabe Pharma Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 44
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC, Cmax, tmax, Kel, t1/2
- Secondary Outcome Measures
Name Time Method Safety and tolerability evaluation (Adverse events, Physical Examination, Vital Signs, 12-lead ECG, Clinical Lab Test, C-SSRS, BDI-II)