Clinical trial NCT02174510: A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
Official title: A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: pharmacokinetic
lurasidone
single dose
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xuhui Central Hospital, Shanghai
First posted: 2014-06-25
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Detailed description: Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo.

This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).

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 written 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.
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 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 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.

Primary outcomes:
measure: Lurasidone Cmax
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone AUC
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone Tmax
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone λZ
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone t1/2
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone MRT
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone CL/F
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone VZ/F
timeFrame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xuhui Center Hospital
state: Shanghai
Study officials:
affiliation: Xuhui Center Hospital, Shanghai
name: ChaoYing Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu C, Wang Y, Song R, Yu C, Luo X, Jia J. Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects. Clin Drug Investig. 2017 Sep;37(9):861-871. doi: 10.1007/s40261-017-0546-8.