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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0004667

Enrollment

Registered

2020-01-29

Start date

2020-02-12

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1. Single- and multiple-dose administration of 40 mg (Placebo: 4 subjects, MT-5199 : 18 subjects) 2. Single dose administration of 80 mg (Placebo: 4 subjects, MT-5199: 18 subjects)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
AUC, Cmax, tmax, Kel, t1/2	—

Secondary

Measure	Time frame
Safety and tolerability evaluation (Adverse events, Physical Examination, Vital Signs, 12-lead ECG, Clinical Lab Test, C-SSRS, BDI-II)	—

Countries

Korea, Republic of

Contacts

Public ContactJae Seong Oh

Seoul National University Hospital

Outcome results