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| Name | Class |
|---|---|
| Xuhui Central Hospital, Shanghai | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20mg lurasidone | Experimental | single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. |
|
| 40mg lurasidone | Experimental | single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. |
|
| 80mg lurasidone | Experimental | single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20mg lurasidone | Drug | single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lurasidone Cmax | 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 |
| Lurasidone AUC | AUC:Area under the serum concentration-time curve | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| Lurasidone Tmax | Tmax:Time to maximum (peak) drug serum concentration | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| Lurasidone λZ | λZ:Elimination rate constant | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| Lurasidone t1/2 | t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| Lurasidone MRT | MRT:Mean residence time. | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| Lurasidone CL/F | CL/F:Apparent total clearance. | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| Lurasidone VZ/F | VZ/F: Apparent volume of distribution at terminal phase (correlated with λz) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ChaoYing Hu, MD | Xuhui Center Hospital, Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuhui Center Hospital | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28695535 | Derived | 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. |
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Total 72 subjects were screened at the clinical site after obtaining informed consent. The data of informed consent from the first subject was march 2014. A total of 37 subjects were enrolled into the study and were randomized to three test drug groups (8 to 20mg group, 8 to 40mg group, 12 to 80mg group), and 9 subjects received placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | 20mg Lurasidone | 20mg lurasidone: single oral lurasidone. |
| FG001 | 40mg Lurasidone | 40mg lurasidone: single oral lurasidone. |
| FG002 | 80mg Lurasidone | 80mg lurasidone: single oral lurasidone. |
| FG003 | Placebo | Subjects administered placebo tablet at the same time with each lurasidone group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study design included 28 men in the positive drug lurasidone group and 9 in placebo group. All subjects who received lurasidone or placebo were included in the safety population. All subjects who received lurasidone and have evaluable PK data were included in the PK analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 20mg Lurasidone | 20mg lurasidone: single oral lurasidone. |
| BG001 | 40mg Lurasidone | 40mg lurasidone: single oral lurasidone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lurasidone Cmax | Cmax:Maximum (peak) observed drug serum concentration. | ALL 28 subjects who received lurasidone and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
From just after use of the study drug to the study-ending evaluation, up to 11 days.
All 37 subjects who received lurasidone or placebo were included in the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20mg Lurasidone | 20mg lurasidone: single oral lurasidone. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof.Hu Chaoying | Shanghai Xuhui Central Hospital, Drug Clinical Trial Institution | 13816319160 | cyhu@shxh-centerlab.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| 40mg lurasidone | Drug | single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. |
|
| 80mg lurasidone | Drug | single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1. |
|
| placebo | Drug |
|
| pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
| BG002 | 80mg Lurasidone | 80mg lurasidone: single oral lurasidone. |
| BG003 | Placebo | Subjects administered placebo tablet at the same time with each lurasidone group. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
80mg lurasidone: single oral lurasidone.
|
|
| Primary | Lurasidone AUC | AUC:Area under the serum concentration-time curve | Posted | Geometric Mean | Geometric Coefficient of Variation | ng・h/mL | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| Primary | Lurasidone Tmax | Tmax:Time to maximum (peak) drug serum concentration | Posted | Median | Full Range | h | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| Primary | Lurasidone λZ | λZ:Elimination rate constant | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| Primary | Lurasidone t1/2 | t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve | Posted | Geometric Mean | Geometric Coefficient of Variation | h | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| Primary | Lurasidone MRT | MRT:Mean residence time. | Posted | Geometric Mean | Geometric Coefficient of Variation | h | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| Primary | Lurasidone CL/F | CL/F:Apparent total clearance. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| Primary | Lurasidone VZ/F | VZ/F: Apparent volume of distribution at terminal phase (correlated with λz) | Posted | Geometric Mean | Geometric Coefficient of Variation | L | pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose |
|
|
|
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | 40mg Lurasidone | 40mg lurasidone: single oral lurasidone. | 0 | 8 | 7 | 8 |
| EG002 | 80mg Lurasidone | 80mg lurasidone: single oral lurasidone. | 0 | 12 | 12 | 12 |
| EG003 | Placebo | Subjects administered placebo tablet at the same time with each lurasidone group. | 0 | 9 | 5 | 9 |
| Feeling hot | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| AUC0-∞ |
|