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Completed

NCT Number: NCT02174523

Pharmacokinetic Study of Lurasidone After Multiple Oral Administration in Healthy Human Subjects

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Xuhui Center Hospital

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

40mg lurasidone

Drug

Placebo

Drug

Primary outcomes

  1. Lurasidone Cmax

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

    Maximum (peak) observed drug serum concentration.

  2. 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

  3. 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

  4. Lurasidone AUC0-∞

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  5. Lurasidone Tmax

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  6. Lurasidone λz

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  7. Lurasidone t1/2

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  8. Lurasidone MRT

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  9. Lurasidone CL/F

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  10. 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

  11. Lurasidone Vz/F

    Time frame: pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose

  12. Lurasidone Vzss/F

    Time frame: Day 8

  13. Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,

    Time frame: Day 8/Day 1

  14. 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

  15. 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

  16. Lurasidone Cmax

    Time frame: Day8

    Maximum (peak) observed drug serum concentration.

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

Sponsors and collaborators

Lead sponsor

Marubeni Pharmaceuticals (Suzhou) Co., Ltd.

Industry

Collaborators

  • Xuhui Central Hospital, Shanghai

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2014
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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