Clinical trial NCT02174523: Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
Official title: Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: pharmacokinetic
lurasidone
multiple dose
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xuhui Central Hospital, Shanghai
First posted: 2014-06-25
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Single oral administration of 40 mg study drug lurasidone or placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg study drug lurasidone or placebo, once daily between Day 4 and Day 8.

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.

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 0-24
timeFrame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone AUC 0-τ
timeFrame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone AUC0-∞
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: CLss/F
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone Vz/F
timeFrame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
measure: Lurasidone Vzss/F
timeFrame: Day 8
measure: Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,
timeFrame: Day 8/Day 1
measure: Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5
timeFrame: Pre-dose (-0.5h) of Day4 and Day5
measure: Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7
timeFrame: Pre-dose (-0.5h) of Day6 and Day7
measure: Lurasidone Cmax
timeFrame: Day8
measure: Lurasidone AUC 0-24
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone AUC 0-τ
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone AUC0-∞
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone Tmax
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone λz
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone t1/2
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
measure: Lurasidone MRT
timeFrame: Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8
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.