| Eligibility |
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 =<25.0 kg/m^2 at the
Screening Visit.
5. The participant must be a current nonsmoker who has not used tobacco- or
nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the
first dose of study drug or first invasive procedure.
6. The participant must be judged to be in good health by the investigator, based on
clinical evaluations including laboratory safety tests, medical history, physical
examination, 12-lead electrocardiogram, and vital sign measurements performed at the
Screening Visit and prior to the first dose of study drug.
7. The participant must meet the following birth control requirements:
- Is a male participant who is sterile or agrees to use an appropriate method of
contraception, including a condom with spermicidal cream or jelly, from the first
dose of study drug until 90 days after the last dose of study drug. No
restrictions are required for a vasectomized male participant provided the
participant is at least 1-year postbilateral vasectomy procedure prior to the
first dose of study drug. A male participant whose vasectomy procedure was
performed less than 1 year prior to the first dose of study drug must follow the
same restrictions as a nonvasectomized man. Appropriate documentation of surgical
procedure should be provided.
- Is a male participant who agrees to not donate sperm from the first dose of study
drug until 90 days after the last dose of study drug.
- Is a female participant of nonchildbearing potential, defined by at least 1 of
the following criteria:
1. Postmenopausal (defined as 12 months of spontaneous amenorrhea in females
aged >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.
2. Hysterectomy and/or bilateral oophorectomy with appropriate documentation of
surgical procedure.
3. Had a tubal ligation with appropriate documentation of surgical procedure.
4. Congenital conditions such as uterine aplasia etc.
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 protocol or is
unsuitable for any other reason.
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