Healthy Chinese Participants
Conditions
Interventions
Test group:On day 1 (visit 2), healthy participants will be administered a 12-mg tablet of TEV-50717 under fed conditions.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy participants may be included in this trial only if they meet all of the following criteria: a. is capable of giving signed informed consent b. is male or female 18 through 45 years of age (at the time the healthy participant signs informed consent) c. is healthy based on results of medical evaluation including medical and psychiatric history, physical examination, neurological examination, clinical laboratory tests, vital signs, and ECG d. has a body weight of male = 50 kg, female = 45 kg, inclusive, and a body mass index within the range of 18.5 to 26 kg/m2, inclusive e. is a CYP2D6 extensive metabolizer or intermediate metabolizer genotype or a combination of the 2 Note: genetic testing is needed either by blood sample or buccal swab f. female participants of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1 year postmenopausal (no menses for at least 12 months without an alternative medical cause plus an increased concentration of follicle stimulating hormone [FSH] of more than 35 U/L in women not using hormonal contraception or hormonal replacement therapy) g. female participants of childbearing potential must have a negative beta-human chorionic gonadotropin (ß-HCG) result and practice a highly effective method of birth control (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly) within 3 months before single dose administration and until 45 days after discontinuation of treatment (further details are included in Appendix B) h. is willing and able to comply with trial restrictions and to remain at the clinic for the required duration during the trial period, and willing to return to the trial site 24 to 72 hours after discharge from the clinic
Exclusion criteria
Exclusion criteria: Healthy participants will be excluded from participating in this trial if they meet any of the following criteria: a. currently has or has history of clinically significant renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal, immunological, endocrine, metabolic, neurological, or psychiatric diseases or disorders, or the presence or history of any illness that, in the opinion of the principal investigator, might pose additional risk to the healthy participant by participation in the trial or confound the results of the trial b. has an ultrarapid or poor CYP2D6 metabolizer genotype c. has a positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C d. has had major trauma or surgery within the 2 months before screening or at any time between screening and single dose administration of investigational medicinal product (IMP), or surgery scheduled during the trial or follow-up period e. has history of malignancy or treatment of malignancy in the last 5 years, excluding basal cell carcinoma f. is a pregnant or lactating woman, or plans to become pregnant during the trial g. has known hypersensitivity or idiosyncratic reaction to active components of the IMP, its related compounds, or to any metabolites, or any compound listed as being present in a trial formulation h. has donated blood or blood products (eg, white blood cells, platelets, etc) within the 90 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or healthy participant has donated plasma within 7 days of the screening visit, or has planned donations up until 2 months following the last dose of IMP, or has received blood or blood products in the 6 weeks before screening i. has a clinically significant illness or active infection (acute or chronic) within 14 days before IMP administration j. has history of suicidal ideation with an intent and/or plan and behavior based on either clinical history, source documents, or C-SSRS scoring that is considered clinically significant per the investigator k. has gone through a procedure or suffered from a disorder (including, but not limited to, gastric bypass surgery, lap band, malabsorption syndrome, and inflammatory bowel disease) that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery; a history of appendectomy and/or cholecystectomy >1 year prior to screening is allowed) l. has any complete blood count with differential, clinical chemistry, or urine laboratory parameter that is outside of the normal reference range that is deemed clinically significant by the investigator at screening; abnormal laboratory values may be retested per the investigator’s clinical discretion m. has a clinically significant deviation from the normal in physical or neurological examination findings, as determined by the investigator n. has a clinically significant abnormality of 12-lead ECG that may, in the opinion of the investigator, interfere with trial participation o. has a 12 lead ECG demonstrating intraventricular conduction delays (QRS interval =120 msec or PR interval =220 msec and resting QT interval with Fridericia’s correction interval of >450 msec) p. has a personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first degree relative, or long QT syndrome, or a personal history of syncope, or previous treatment for high blood pressure q. has a b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Tolerability; | — |
Countries
China
Contacts
Public ContactLi Zheng
West China Hospital of Sichuan University
Outcome results
None listed