Overview

Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Collaborator:
Xuhui Central Hospital, Shanghai
Treatments:
Lurasidone Hydrochloride
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.