Healthy Adult Asian Participants
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-831
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for I
TAK-831 100 mg + TAK-831 300 mg: TAK-831 100 mg, tablets, orally, once daily on Day 1, followed by TAK-831 300 mg, tablets, orally, once daily on Day 9 in healthy Japanese participants.
Generic name e
TAK-831 100 mg + Placebo: TAK-831 100 mg, tablets, orally, once daily on Day 1 followed by TAK-831 matching placebo, tablets, orally, once daily on Day 9 in healthy Japanese participants.
Generic name
Placebo + TAK-831 300 mg: TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 300 mg, tablets, orally, once daily on Day 9 in healthy Japanese participants.
Generic name
TAK-831 300 mg: TAK-831 300 mg or TAK-831 matching placebo, tablets, orally, once daily on Day 1 followed by TAK-831 300 mg or TAK-831 matching placebo, tablets, orally, once daily from Day 4 to Day 1
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 (for Chinese participants, an interpreter should be present as necessary). 2. The participant must be willing and able to comply with all study procedures and restrictions. 3. The participant must be male or female (of nonchildbearing potential) aged 20 to 55 years, inclusive, at the Screening. 4. The participant must have a body mass index (BMI) >=18.5 kg/m^2 and =<25.0 kg/m^2 at the Screening. 5. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (e.g., nicotine patch) for at least 6 months prior to the Screening. 6. Chinese participants are defined as participants who were born in mainland China, and their biological parents and grandparents must all have been of Chinese origin (for Cohort 3 only). 7. Chinese participants who have lived out of China for more than 5 years must not have significantly modified their diets since leaving China (for Cohort 3 only). 8. The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory tests, medical history, full physical examination, 12-lead electrocardiogram, and vital sign measurements performed at the Screening and prior to the first dose of study drug. 9. The participant must meet the birth control requirements.
Exclusion criteria
Exclusion criteria: 1. The participant has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary, or presents with major neurological (including stroke and chronic seizures) abnormalities or diseases. 2. The participant has participated in another investigational trial within 4 weeks before the pretrial visit (Screening). The 4-week window will be derived from the date of the last trial procedure and/or adverse event (AE) related to the trial procedure in the previous trial to the Screening Visit of the current trial. 3. The participant is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor. 4. The participant has a history of cancer (malignancy). 5. The participant has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food. 6. The participant has a positive alcohol or drug or immunological screen. 7. The participant is of childbearing potential or lactating. 8. The participant had major surgery, received or lost 1 unit of blood (approximately 500 milliliters [mL]) within 8 weeks prior to the first dose of study drug. 9. The participant with any GI (gastrointestinal) surgery that could impact upon the absorption of study drug. 10. The participant has a known hypersensitivity to any component of the formulation of TAK-831 or related compounds. 11. The participant 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 trial drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit. 12. The participant has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day). 13. The participant who 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. 14. The participant has a history of drug abuse. 15. The participant has a (QT interval with Fridericia's correction method) QTcF >450 milliseconds (msec) (males) or >470 msec (females) or PR outside the range of 120 to 220 msec at the Screening Visit or Check-in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Number of Participants Reporting at Least One Treatment-emergent Adverse Events (TEAEs) Timeframe; Cohort 1; Baseline up to Day 23; Cohorts 2-5; Baseline up to Day 31 safety Number of Participants Reporting at Least One TEAEs Related to Laboratory Tests Results Timeframe; Cohort 1; Baseline up to Day 23; Cohorts 2-5; Baseline up to Day 31 safety Number of Participants Reporting at Least One TEAEs Related to Vital Sign Timeframe; Cohort 1; Baseline up to Day 23; Cohorts 2-5; Baseline up to Day 31 safety Number of Participants Reporting at Least One TEAEs Related to Body Weight Timeframe; Cohort 1; Baseline up to Day 23; Cohorts 2-5; Baseline up to Day 31 safety Number of Participants Reporting at Least One TEAEs Related to 12-lead Electrocardiogram (ECG) Parameters Timeframe; Cohort 1; Baseline up to Day 23; Cohorts 2-5; Baseline up to Day 31 | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Cmax; Maximum Observed Plasma Concentration for TAK-831 Timeframe; Cohort 1;Day 1;pre-dose and at multiple time points (up to 72 hours; 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours) post-dose, Cohorts 2 to 5; Day 1; pre-dose and at multiple time points (up to 72 hours; 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours) post-dose pharmacokinetics Cmax,ss; Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831 Timeframe; Cohorts 2 to 5; Day 17; pre-dose and at multiple time points (up to 24 hours; 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 Hours) post-dose pharmacokinetics Tmax; Time of First Occurrence of Cmax for TAK-831 Timeframe; Cohort 1 Day 1; pre-dose and at multiple time points (up to 72 hours; 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours) post-dose, Cohorts 2 to 5; Days 1 and 17; pre-dose and at multiple time points (up to 72 hours; 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours [Day 1], up to 24 hours; 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 Hours [Day 17]) post-dose pharmacokinetics AUClast; Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831 Timeframe; Cohort 1; Day 1; pre-dose and at multiple time points (up to 72 hours; 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours) post-dose, Cohorts 2 to 5; pre-dose and at multiple time points (up to 72 hours ; 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours [Day 1]) post-dose pharmacokinetics AUC (infinity); AUC from Time 0 to Time of Infinity for TAK-831 Timeframe; Cohort 1; Day 1; pre-dose and at multiple time points (up to 72 hours; 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours) post-dose, Cohorts 2 to 5; Day 1; pre-dose and at multiple time points (up to 72 hours; 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48 and 72 Hours) post-dose pharmacokinetics AUCtau; AUC During a Dosing Interval for TAK-831 Timeframe; Cohorts 2 to 5; Days 1 and 17; pre-dose and at m | — |
Countries
Japan
Outcome results
None listed