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

NCT02174510 | Completed Phase 1 Results

• 1 other identifier: D1070002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

pharmacokinetic; lurasidone; single dose

Outcome Measures

Primary Outcomes (8)

• Lurasidone Cmax

  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

  AUC：Area under the serum concentration-time curve

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

• Lurasidone Tmax

  Tmax：Time to maximum (peak) drug serum concentration

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

• Lurasidone λZ

  λZ：Elimination rate constant

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

• Lurasidone t1/2

  t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve

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

• Lurasidone MRT

  MRT：Mean residence time.

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

• Lurasidone CL/F

  CL/F：Apparent total clearance.

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

• Lurasidone VZ/F

  VZ/F: Apparent volume of distribution at terminal phase (correlated with λz)

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

Study Arms (3)

20mg lurasidone

EXPERIMENTAL

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; Drug: placebo

40mg lurasidone

EXPERIMENTAL

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; Drug: placebo

80mg lurasidone

EXPERIMENTAL

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; Drug: placebo

Interventions

20mg lurasidone DRUG

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

20mg lurasidone

40mg lurasidone DRUG

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

40mg lurasidone

80mg lurasidone DRUG

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

80mg lurasidone

placebo DRUG

20mg lurasidone; 40mg lurasidone; 80mg lurasidone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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 written 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.
• 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 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 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.

Sponsors & Collaborators

• Sumitomo Pharma (Suzhou) Co., Ltd.: lead
• Xuhui Central Hospital, Shanghai: collaborator

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: 28695535 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Prof.Hu Chaoying
• Organization: Shanghai Xuhui Central Hospital, Drug Clinical Trial Institution

cyhu@shxh-centerlab.com

13816319160

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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: June 25, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 11, 2019
• Results First Posted: January 11, 2019

Record last verified: 2018-05

Locations

CN (1)