Lurasidone Pediatric Pharmacokinetics Study

NCT01620060 | Completed Phase 1 Results

• 1 other identifier: D1050300
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 10

Brief Summary

This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.

Conditions

Schizophrenia; Autism

Keywords

Schizophrenia; autism; bipolar; Lurasidone; Latuda

Outcome Measures

Primary Outcomes (2)

• Lurasidone Primary Pharmacokinetic Parameters

  Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)

  Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

• Lurasidone Peak Serum Concentration (Cmax)

  Cmax will be listed and summarized in tabular format

  Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours

Secondary Outcomes (1)

• Number of Participants With Serious Adverse Events and Non-serious Adverse Events

  11 Days

Study Arms (1)

Lurasidone oral tablets

EXPERIMENTAL

Lurasidone 20, 40, 80, 120 or 160 mg/day

Drug: Lurasidone

Interventions

Lurasidone DRUG

Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days

Lurasidone oral tablets

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must provide written informed consent, if emancipated, written assent and be willing to participate in the study. Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' adherence to the study procedures must be obtained for subjects who are not emancipated.
• Male or female subjects 6 to 17 years of age, inclusive. Subject must be 17 years or less at the follow-up visit.
• Subject is judged by the investigator to be clinically stable (ie, no psychiatric hospitalization within the past 12 weeks; no imminent risk of suicide or injury to self, others or property; no recent addition, or change in dosage, of psychotropic medication intended for the treatment of the primary psychiatric condition in the past 4 weeks) but symptomatic (ie, some active symptoms of the primary psychiatric condition are present for which an atypical antipsychotic agent is judged to be an acceptable treatment option).
• Subjects with the following diagnoses will be eligible for participation: primary schizophrenia spectrum diagnosis (schizophrenia, schizoaffective, schizophreniform or psychotic disorder Not Otherwise Specified (NOS), bipolar spectrum disorder (bipolar I, II or bipolar NOS), pervasive developmental disorder (PDD) including autistic spectrum disorder (autistic disorder, Asperger's syndrome, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), attention-deficit hyperactivity (ADHD) with aggressive behavior \[meeting co-morbid diagnostic criteria for Conduct Disorder/Disruptive Behavior Disorders Not Otherwise Specified (CD/DBD NOS), or Tourette's syndrome, via clinical interview (using MINI-Kid plus diagnostic interview and the Diagnostic and Statistical Manual of Mental Disorders, 4th edition Text Revision (DSM-IV-TR) as a reference). Autistic disorder should also be confirmed by the Autism Diagnostic Interview, Revised (ADI-R).
• Within 5th to 95th percentile for gender specific weight-for-age and height-for-age Growth Charts from National Center for Health Statistics.
• No clinically relevant abnormal laboratory values.
• No clinically relevant abnormal vital sign values/findings.
• Females who participate in this study:
• are unable to become pregnant (eg, premenarchal, surgically sterile etc) -OR-
• are willing to remain sexually abstinent (not engage in sexual intercourse) from Day 1 to 30 days after discharge on Day 11; -OR-
• are sexually active and willing to use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from Day -1 to 30 days after discharge on Day 11.
• Males must be willing to remain sexually abstinent or use an effective method of birth control (eg, condom) from Day -1 to 30 days after discharge on Day 11.
• Willing and able to remain off any antipsychotic medication other than lurasidone for the duration of the study, if, in the investigator's opinion the subject is not at risk for worsening symptoms.
• Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
• Willing and able to adhere to protocol-specified meal requirements during dosing.

You may not qualify if:

• Clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subjects if they were to participate in the study or that might confound the results of the study.
• Known presence or history of hepatic insufficiency or subject's estimated creatinine clearance is \< 80 mL/min/1.73 m2 by the following Bedside Schwartz equation for use with creatinine methods with calibration traceable to isotope dilution mass spectrometry (IDMS): Creatinine clearance (mL/min/1.73 m2) = (0.41 height) / serum creatinine concentration, where height in cm and serum creatinine in mg/dL.
• Clinically significant finding(s) on physical examination determined by the investigator to pose a health concern to the subject while on study.
• A history or presence of abnormal ECG, which in the investigator's opinion is clinically significant. Screening ECGs will be centrally over-read, and eligibility will be determined based on the over-read.
• Known history or presence of clinically significant intolerance to any antipsychotic medications including but not limited to angioedema, serotonin or neuroleptic malignant syndromes, moderate to severe dystonia, or moderate to severe tardive dyskinesia.
• Clinically significant alcohol abuse/dependence or drug abuse/dependence based on MINI-Kid criteria within the last 6 months prior to screening.
• Clinically significant orthostatic hypotension (ie, a drop in systolic blood pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or more within 3 minutes of standing up).
• Presence or history (within the last year) of a medical or surgical condition (eg, gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
• Positive breath alcohol test at screening or on Day -1.
• Positive test results at screening or on Day -1 for:
• Pregnancy test (only in female subjects ≥ 8 years old).
• Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS), or history of Hepatitis B or C, or a positive test for Hepatitis B or C at screening (for subjects without a history).
• Participated in another clinical trial or receiving an investigational product within 30 days prior to study drug administration.
• Use of any inhibitor or inducer of CYP3A4 taken within 28 days prior to drug administration and until discharge on Day 11. Exceptions (eg, for grapefruit juice consumption) may be discussed on a case-by-case basis with the medical monitor.
• Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to Day -1 to follow-up.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (10)

Woodland International Research Group, Inc.

Little Rock, Arkansas, 72223, United States

Location

Woodland Northwest Research, LLC

Springdale, Arkansas, 72704, United States

Location

World Wide Research Centers Inc.

Murrieta, California, 92562, United States

Location

Segal Institute for Clinical Research

Fort Lauderdale, Florida, 33301, United States

Location

Miami Children's Hospital

South Miami, Florida, 33143, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

University of Cincinnati, Dept. of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

CRI Worldwide, LLC

Philadelphia, Pennsylvania, 19139, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

Related Publications (1)

• Findling RL, Goldman R, Chiu YY, Silva R, Jin F, Pikalov A, Loebel A. Pharmacokinetics and Tolerability of Lurasidone in Children and Adolescents With Psychiatric Disorders. Clin Ther. 2015 Dec 1;37(12):2788-97. doi: 10.1016/j.clinthera.2015.11.001. Epub 2015 Nov 26.

  PMID: 26631428 DERIVED

MeSH Terms

Conditions

Schizophrenia; Autistic Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental 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: Medical Director, CNS
• Organization: Sunovion

1-866-503-6351

Study Officials

• Lurasidone Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: June 15, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 8, 2016
• Results First Posted: July 31, 2014

Record last verified: 2016-03

Locations

US (10)