Pharmacokinetic Study of Lurasidone After Multiple Oral A... | NCT02174523

NCT02174523

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Xuhui Central Hospital, Shanghai	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
40mg lurasidone	Experimental	Single oral administration of 40 mg study drug lurasidone 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, once daily between Day 4 and Day 8.	Drug: 40mg lurasidone
placebo	Placebo Comparator	Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8.	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
40mg lurasidone	Drug		40mg lurasidone
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Lurasidone AUC 0-24		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC 0-τ		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone AUC0-∞		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone Tmax		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone λz		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone t1/2		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone MRT		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
Lurasidone CL/F		pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Male subjects are 18≤ age <40 years of age when signing the informed consent.
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.
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:

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).
Subjects with past diabetic history.
Subjects has an HbA1c level of >6.2% at screening.
Subjects with history of gastrointestinal operations (excluding appendectomy).
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.
Subjects with past history of allergy to drugs.
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).
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.
Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
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).
Subjects have history of drug abuse or positive urine drug tests.
Subjects with positive immunologic test results.
Average amount of daily smoking>20 cigarettes.
Subjects have taken other study drugs within 3 months (Day_-90~Day 1) before medication.
Subjects received lurasidone orally before.
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.
Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day_-3) and before administration of study drug on medication day.
Subjects can not tolerate venipuncture or have poor peripheral venous access.
Subjects are unwilling to abstain from vigorous exercise from Day_-1 until discharge.
Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.

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.

ID	Title	Description
FG000	40mg Lurasidone	Single oral administration of 40 mg study drug lurasidone 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, once daily between Day 4 and Day 8.
FG001	Placebo	Single oral administration of 40 mg study drug placebo after the over 350 kcal breakfast on Day 1. Administration was suspended on Days 2 and 3. Continuous oral administration of 40 mg placebo, once daily between Day 4 and Day 8.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	40mg Lurasidone	Single oral administration of 40 mg study drug lurasidone 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, once daily between Day 4 and Day 8.
BG001	Placebo

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Maximum (peak) observed drug serum concentration.

All subjects with evaluable PK data were included in PK data analysis.

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

ID	Title	Description
OG000	40mg Lurasidone	Single oral administration of 40 mg study drug lurasidone 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, once daily between Day 4 and Day 8.

Units	Counts

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	40mg Lurasidone	Single oral administration of 40 mg study drug lurasidone 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, once daily between Day 4 and Day 8.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles