NCT02174523

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

February 11, 2014

Results QC Date

May 31, 2018

Last Update Submit

January 9, 2019

Conditions

Schizophrenia

Keywords

pharmacokineticlurasidonemultiple dose

Outcome Measures

Primary Outcomes (23)

  • 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

  • Lurasidone Vz/F

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

  • Lurasidone Vzss/F

    Day 8

  • Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,

    Day 8/Day 1

  • Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5

    Pre-dose (-0.5h) of Day4 and Day5

  • Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7

    Pre-dose (-0.5h) of Day6 and Day7

  • Lurasidone Cmax

    Maximum (peak) observed drug serum concentration.

    Day8

  • Lurasidone AUC 0-24

    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

  • Lurasidone AUC 0-τ

    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

  • Lurasidone AUC0-∞

    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

  • Lurasidone Tmax

    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

  • Lurasidone λz

    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

  • Lurasidone t1/2

    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

  • Lurasidone MRT

    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

Study Arms (2)

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

Interventions

40mg lurasidoneDRUG
40mg lurasidone
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuhui Center Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

  • 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.

    PMID: 28695535DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr.Hu Chaoying
Organization
Phase I Clinical Research Unit , Shanghai Xuihui Central Hospital
cyhu@shxh-centerlab.com
021-54036058

Study Officials

  • ChaoYing Hu, MD

    Xuhui Center Hospital, Shanghai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

June 25, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 8, 2019

Results First Posted

April 8, 2019

Record last verified: 2014-06

Locations

CN(1)