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A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174510
Recruitment Status : Completed
First Posted : June 25, 2014
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Xuhui Central Hospital, Shanghai
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: 20mg lurasidone Drug: 40mg lurasidone Drug: 80mg lurasidone Drug: placebo Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects
Study Start Date : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: 20mg lurasidone
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.
Drug: 20mg lurasidone
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.

Drug: placebo
Experimental: 40mg lurasidone
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.
Drug: 40mg lurasidone
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.

Drug: placebo
Experimental: 80mg lurasidone
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.
Drug: 80mg lurasidone
single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.

Drug: placebo



Primary Outcome Measures :
  1. Lurasidone Cmax [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    Cmax:Maximum (peak) observed drug serum concentration.

  2. Lurasidone AUC [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    AUC:Area under the serum concentration-time curve

  3. Lurasidone Tmax [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    Tmax:Time to maximum (peak) drug serum concentration

  4. Lurasidone λZ [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    λZ:Elimination rate constant

  5. Lurasidone t1/2 [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve

  6. Lurasidone MRT [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    MRT:Mean residence time.

  7. Lurasidone CL/F [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    CL/F:Apparent total clearance.

  8. Lurasidone VZ/F [ Time Frame: pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose ]
    VZ/F: Apparent volume of distribution at terminal phase (correlated with λz)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 written 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.
  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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174510


Locations
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China, Shanghai
Xuhui Center Hospital
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Xuhui Central Hospital, Shanghai
Investigators
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Principal Investigator: ChaoYing Hu, MD Xuhui Center Hospital, Shanghai
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02174510    
Other Study ID Numbers: D1070002
First Posted: June 25, 2014    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: May 2018
Keywords provided by Sumitomo Pharmaceutical (Suzhou) Co., Ltd.:
pharmacokinetic
lurasidone
single dose
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents