Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: 40mg lurasidone; placebo
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetic; lurasidone; multiple dose

Summary:

      To evaluate the pharmacokinetic (PK) characteristics after multiple oral administration of 40
      mg lurasidone in healthy Chinese subjects.

      To evaluate the safety and tolerance after multiple oral administration of 40 mg lurasidone
      in healthy Chinese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. After detailed explanations of study objectives, methods and procedures, anticipated
             efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware
             of all relevant information related to this study and have signed the informed consent
             form voluntarily.

          2. Male subjects are 18≤ age <40 years of age when signing the informed consent.

          3. Subjects with body weight of 50.0≤ and ≤80.0 kg and BMI (body mass index) of 19.0≤ and
             <24.0 at screening examination.

          4. Subjects are able to comply with all requirements during this study period, receive
             various physical and laboratory examinations per study protocol, and report subjective
             symptoms.

        Exclusion Criteria:

          1. Based on the examination results during screening period, various physical and
             laboratory examinations performed 1 day before medication (Day -1) and before
             administration of study drug on the medication day, there are certain medical concerns
             on subject's health status in principal investigator's or study supervising
             physician's opinions (certain treatment or medical observation are deemed necessary).

          2. Subjects with past diabetic history.

          3. Subjects has an HbA1c level of >6.2% at screening.

          4. Subjects with history of gastrointestinal operations (excluding appendectomy).

          5. Because of subjects' past medical history of cardiovascular diseases, liver diseases,
             renal diseases, endocrine disorders, digestive diseases, hematologic diseases,
             respiratory diseases, mental illness, neurological disorders (especially epilepsy and
             other convulsive disorders) and other diseases, subjects are unsuitable to participate
             in this study in the principal investigator's or study supervising physician's
             opinions.

          6. Subjects with past history of allergy to drugs.

          7. Subjects have consumed grapefruit or food containing grapefruit ingredients between 7
             days before medication (Day_-7) and before administration of study drug on the
             medication day (Day 1). Subjects have consumed food containing hypericum perforatum L.
             ingredients between 14 days before medication (Day_-14) and administration of study
             drug on the medication day (Day 1).

          8. Subjects have taken any drugs (including over-the-counter drugs) between 7 days before
             medication (Day_-7) and before administration of study drug on medication day.

          9. Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or
             Chinese liquor≥150 mL).

         10. Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of
             caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or
             nutritional oral solution, etc).

         11. Subjects have history of drug abuse or positive urine drug tests.

         12. Subjects with positive immunologic test results.

         13. Average amount of daily smoking>20 cigarettes.

         14. Subjects have taken other study drugs within 3 months (Day_-90~Day 1) before
             medication.

         15. Subjects received lurasidone orally before.

         16. Subjects have history of blood donations of 400 mL within 3 months (Day_-90~Day 1)
             before medication; 200 mL within 1 month (Day_-30~Day 1) before medication; or
             donation of blood components within 2 weeks (Day_-14~Day 1) before medication.

         17. Subjects have consumed alcohol-containing food between 3 days before medication 3
             (Day_-3) and before administration of study drug on medication day.

         18. Subjects can not tolerate venipuncture or have poor peripheral venous access.

         19. Subjects are unwilling to abstain from vigorous exercise from Day_-1 until discharge.

         20. Other subjects who are unsuitable to participate in this study in principal
             investigator's or study supervising physician's opinions.