Schizophrenia Clinical Trial
Official title:
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
NCT number | NCT02174523 |
Other study ID # | D1070003 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | April 2014 |
Est. completion date | April 2014 |
Verified date | June 2014 |
Source | Sumitomo Pharmaceutical (Suzhou) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Xuhui Center Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | Xuhui Central Hospital, Shanghai |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lurasidone Cmax | Maximum (peak) observed drug serum concentration. | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | |
Primary | Lurasidone AUC 0-24 | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone AUC 0-t | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone AUC0-8 | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone Tmax | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone ?z | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone t1/2 | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone MRT | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone CL/F | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | CLss/F | 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 | ||
Primary | Lurasidone Vz/F | pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose | ||
Primary | Lurasidone Vzss/F | Day 8 | ||
Primary | Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-8,Ratio of AUC0-t, | Day 8/Day 1 | ||
Primary | Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5 | Pre-dose (-0.5h) of Day4 and Day5 | ||
Primary | Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7 | Pre-dose (-0.5h) of Day6 and Day7 | ||
Primary | Lurasidone Cmax | Maximum (peak) observed drug serum concentration. | Day8 | |
Primary | Lurasidone AUC 0-24 | 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 | ||
Primary | Lurasidone AUC 0-t | 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 | ||
Primary | Lurasidone AUC0-8 | 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 | ||
Primary | Lurasidone Tmax | 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 | ||
Primary | Lurasidone ?z | 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 | ||
Primary | Lurasidone t1/2 | 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 | ||
Primary | Lurasidone MRT | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |