schizophrenia MedDRA version: 14.1 Level: LLT Classification code 10001064 Term: Acute schizophrenia System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Lurasidone
Product Name: Lurasidone
Product Code: SM-13496
Pharmaceutical Form: Tablet
INN or Proposed INN: Lurasidone
CAS Number: 367514-88-3
Other descriptive name: Lurasidone Hydrochlor
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must provide written informed 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. 2. Male or female subjects 6 to 17 years of age, inclusive. 3. Subject is judged by the investigator to be clinically stable (i.e., 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 (i.e., some active symptoms of the primary psychiatric condition are present for which an atypical antipsychotic agent is judged to be an acceptable treatment option). 4. 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). 5. 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. 6. Willing and able to swallow the size and number of lurasidone tablets specified per protocol. 7. Have a stable living arrangement for at least 3 months prior to Day -1 and agrees to return to a similar living arrangement after discharge on Day 11. Homeless subjects may not be enrolled. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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 x height) / serum creatinine concentration, where height in cm and serum creatinine in mg/dL. 3. 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. 4. Clinically significant alcohol abuse/dependence or drug abuse/dependence based on MINI-Kid criteria within the last 6 months prior to screening. 5. Clinically significant orthostatic hypotension (i.e., 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). 6. Use of any inhibitor or inducer of CYP3A4 taken within 28 days prior to drug administration and until discharge on Day 11. Exceptions (e.g., for grapefruit juice consumption) may be discussed on a case-by-case basis with the medical monitor. 7. Use of concomitant medications that consistently prolong the QT/QTc interval within 28 days prior to Day -1 to follow-up. 8. Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine or fluvoxamine, within 3 days prior to Day -1 (7 days prior to Day -1 for aripiprazole) and until follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the pharmacokinetics (PK) and assess safety and tolerability of single and multiple oral doses of 20, 40, 80, 120, or 160 mg/day lurasidone in subjects 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders;Secondary Objective: To characterize the PK for metabolites of lurasidone (ID 14283, ID 14326, ID-11614, ID 20219, and ID-20220) following single and multiple oral doses of 20, 40, 80, 120, or 160 mg/day lurasidone in subjects 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders;Primary end point(s): Characterize the pharmacokinetics (PK) of lurasidone following single and multiple oral doses of 20, 40, 80, 120 or 160 mg/day lurasidone;Timepoint(s) of evaluation of this end point: approximately 53 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Determine the and tolerability of 20, 40, 80, 120 or 160 mg/day lurasidone;Timepoint(s) of evaluation of this end point: approximately 53 days | — |
Countries
United States
Contacts
Public ContactYu-Yuan Chiu
Sunovion Pharmaceuticals Inc.
Outcome results
None listed