Japanese healthy adult
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-935
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administration for Investigational material :
TAK-935 200 mg, tablets, orally once on Days 1 in fasted state.
Generic name etc : TAK-935
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administra
TAK-935 600 mg, tablets, orally once on Days 1 in fasted state.
Generic name etc : TAK-935
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administra
TAK-935 1200 mg, tablets, orally once on Days 1 in fasted state.
Generic name etc : TAK-935
INN of investigational material : -
Therapeutic category code : 117 Psychotropic agents
Dosage and Administr
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant must understand the study procedures and agree to participate by providing written informed consent. 2. The participant must be willing and able to comply with all study procedures and restrictions. 3. The participant must be a Japanese healthy adult male or female, aged 20 to 55 years, inclusive, at the time of informed consent. 4. The participant must have a body mass index (BMI) >=18.5 and =45 years or >=6 months of spontaneous amenorrhea in females aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 mIU/mL). Appropriate documentation of follicle-stimulating hormone levels should be required. b. Hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure. c. Had a tubal ligation with appropriate documentation of surgical procedure. d. Congenital conditions such as uterine aplasia etc.
Exclusion criteria
Exclusion criteria: 1. Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular (including arrhythmia), hematological, hepatic, immunological, renal, respiratory, genitourinary, major neurological (including stroke, epileptic seizure), or degenerative ophthalmological abnormalities or diseases 2. Has participated in another investigational trial within 4 weeks or 5 half-lives (whichever is longer) before the pretrial visit (Screening). The 4-week or 5 half-lives window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial. 3. Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the sponsor. 4. Has a history of cancer (malignancy). 5. Has any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within 12 months, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS) or is clinically judged by the investigator to be at risk for suicide. 6. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food. 7. Has a positive alcohol or drug screen. 8. Had major surgery, donated or lost whole blood prior to the start of study drug administration as any of below: For both male and female participants, >=200 mL within 4 weeks (28 days) For male participants, >=400 mL within 12 weeks (84 days), >=800 mL in total within 52 weeks (364 days) For female participants, >=400 mL within 16 weeks (112 days). >=400 mL in total within 52 weeks (364 days) 9. Had gastrointestinal surgery that could impact the absorption of study drug. 10. Has a history of a major psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria. 11. Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds. 12. Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies, beginning approximately 7 days before administration of the initial dose of study drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit. 13. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. 14. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. 15. Has a substance abuse disorder. 16. Has a QTcF >450 msec confirmed with one repeat testing, at the Screening Visit. 17. Had abnormal Screening or Day -1 laboratory values that suggested a clinically significant underlying disease or participant with the following laboratory abnormalities: ALT and/or AST >1.5 time ULN. 18. Has tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody/antigen, or serologic reactions for syphilis at Screening. 19. In the opinion of the investigator, is unlikely to comply with the proto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Parts 1 and 2: Percentage of Participants who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE) Time Frame: Part 1: Up to Day 8, Part 2: Up to Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-935 Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose pharmacokinetics Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-935 Time Frame: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose pharmacokinetics Part 1, AUClast: Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for TAK-935 Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose pharmacokinetics Part 1, AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Time of Infinity for TAK-935 Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose pharmacokinetics Part 1, AUC(0-24): Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours Post-dose for TAK-935 Time Frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose pharmacokinetics Part 2, AUCtauss: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State for TAK-935 Time Frame: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose | — |
Countries
Japan
Outcome results
None listed