- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174523
Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects
January 9, 2019 updated by: Sumitomo Pharma (Suzhou) Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200031
- Xuhui Center Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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|
Placebo Comparator: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lurasidone Cmax
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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Maximum (peak) observed drug serum concentration.
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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Lurasidone AUC 0-24
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
|
pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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|
Lurasidone AUC 0-τ
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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|
Lurasidone AUC0-∞
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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|
Lurasidone Tmax
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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Lurasidone λz
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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Lurasidone t1/2
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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|
Lurasidone MRT
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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Lurasidone CL/F
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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CLss/F
Time Frame: 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
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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
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Lurasidone Vz/F
Time Frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose
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Lurasidone Vzss/F
Time Frame: Day 8
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Day 8
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Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,
Time Frame: Day 8/Day 1
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Day 8/Day 1
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Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5
Time Frame: Pre-dose (-0.5h) of Day4 and Day5
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Pre-dose (-0.5h) of Day4 and Day5
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Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7
Time Frame: Pre-dose (-0.5h) of Day6 and Day7
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Pre-dose (-0.5h) of Day6 and Day7
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Lurasidone Cmax
Time Frame: Day8
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Maximum (peak) observed drug serum concentration.
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Day8
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Lurasidone AUC 0-24
Time Frame: 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
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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
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|
Lurasidone AUC 0-τ
Time Frame: 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
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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
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Lurasidone AUC0-∞
Time Frame: 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
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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
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Lurasidone Tmax
Time Frame: 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
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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
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Lurasidone λz
Time Frame: 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
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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
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Lurasidone t1/2
Time Frame: 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
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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
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Lurasidone MRT
Time Frame: 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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (Estimate)
June 25, 2014
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Lurasidone Hydrochloride
Other Study ID Numbers
- D1070003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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