Healthy adult participants
Conditions
Interventions
investigational material(s)
Generic name etc : Vortioxetine one 20 mg tablet + two 10 mg tablets
INN of investigational material : Vortioxetine
Therapeutic category code : 117 Psychotropic agents
Dosa
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be a healthy Japanese adult volunteer. 2. Understand the contents of the study and is capable of providing written consent to participate in the study. 3. Be willing to comply with all study procedures and restrictions. 4. Aged between >=20 and ==18.5 and ==50 kg at the time of screening. 6. Be a extensive metabolizer (EM) based on CYP2D6 genotyping at the time of screening. 7. A female participant of childbearing potential with a non-sterilized male partner must agree to routinely use appropriate contraception during the study from the time of signing informed consent until 4 weeks after last dosing of the study drug.
Exclusion criteria
Exclusion criteria: 1. Has received any investigational drug within 90 days before screening for this study. 2. Previously received Lu AA21004 before participation in this study. 3. Is an employee of the sponsor or the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may be coerced to provide consent. 4. Has uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may affect study participation or study results. 5. Has a history of multiple episodes or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription drugs, over the counter (OTC) drugs, or foods. 6. Has a positive pregnancy test at the time of screening or Day -1. 7. Is a pregnant or lactating female. 8. Has a positive urine drug screen test at the time of screening or Day -1. 9. Has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study. 10. Consumes 6 or more servings of caffeinated beverages (containing about 120 mg of caffeine per serving) such as of coffee, tea, cola, or energy drinks. 11. Is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the Period 1 study drug administration. 12. Used any of the excluded drugs, dietary products or foods during the specified time periods, or will need any of them during the study period. 13. Has any current or recent gastrointestinal diseases that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn), or any surgical intervention (Stomach, cholecystectomy etc.). 14. Has a history of cancer. 15. Has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis. 16. Has poor peripheral venous access. 17. Has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of Period 1 study drug administration. 18. Has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of Period 1 study drug administration. 19. Has undergone blood component collection within 2 weeks (14 days) prior to the start of Period 1 study drug administration. 20. Has any clinically relevant abnormality in vital signs or 12-lead electrocardiograms (ECG) at screening or on Day -1 of Period 1. 21. Has abnormal laboratory test values at screening or on Day -1 of Period 1 indicating clinically relevant underlying disease, or showing alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 x upper limit of normal (ULN). 22. Is unlikely to comply with the protocol requirements or is unsuitable as a participant of this study for any other reason in the opinion of the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics AUClast: Area under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose pharmacokinetics Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics AUCinfinity: Area under the Plasma Concentration-Time Curve from Time 0 to Infinity of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose pharmacokinetics Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose pharmacokinetics MRTinfinity, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose pharmacokinetics MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose pharmacokinetics Apparent Elimination Rate Constant of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose pharmacokinetics T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004 Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose safety Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) Time Frame: Up to Day 25 safety Number of Participants with TEAE Related to Vital Sign Time Frame: Up to Day 25 safety Number of Participants with TEAE Related to Laboratory Test Results Timeframe; Up to Day 25 safety Number of Participants with TEAE Related to 12-lead Electrocardiograms Time Frame: Up to Day 25 | — |
Countries
Japan
Outcome results
None listed