Schizophrenia, Schizoaffective- and Schizophreniform Disorders MedDRA version: 20.0 Level: HLT Classification code 10039620 Term: Schizoaffective and schizophreniform disorders System Organ Class: 100000004873 MedDRA version: 20.0 Level: HLT Classification code 10039631 Term: Schizophrenia NEC System Organ Class: 100000004873
Conditions
Interventions
Product Name: Cariprazine
Product Code: RGH-188
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Cariprazine
CAS Number: 839712-12-8
Current Sponsor code: RGH-188
Other descriptive name: CARIPR
Sponsors
Gedeon Richter Plc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.All patients are required to have a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DSM-5. 2.Adolescent patients have to be between the ages of either 13 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current DSM-5 diagnosis other than schizophrenia, schizoaffective disorder or schizophreniform disorder. 2.Other neurological or behavioral disorders that may interfere with the conduct or interpretation of the study. 3.History of drug abuse according to DSM 5 and/or positive test result from the urine drug screen (UDS). 4.Regular use of alcohol or alcohol abuse or positive alcohol breath test. 5.Being at significant risk of suicide according to the Investigator judgment, based upon all available source of information including C-SSRS. 6.Clinically significant disease state, in the opinion of the examining physician, in any body system. 7.Abnormal and clinically significant results on physical examination, vital signs, medical history, serum chemistry, hematology, or urinalysis. 8.Clinically significant abnormal electrocardiogram (ECG) results. 9.Positive test results for anti–human immunodeficiency virus, hepatitis B surface antigen, anti–hepatitis C virus antibody at screening. 10.Taken strong CYP3A4 inhibitors or inducers within 30 days before first administration of IMP until the last PK sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Assess PK, safety and tolerability of up to 3 doses of once daily cariprazine capsules •Investigate dosing requirements of cariprazine in adolescents •Determination of the PK parameters of cariprazine (CAR) and its two metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR) in adolescents at steady state, compared to adults •Estimation of the inter-individual variability of the PK parameters in the adolescent population •Evaluation of the relationship between different covariates (age, body weight) and the PK parameters •Examination of the dose linearity of exposure in adolescents ;Secondary Objective: Not applicable;Primary end point(s): •PK assessment including determination of the exposure to Cariprazine (CAR), Desmethyl Cariprazine (DCAR) and Didesmethyl Cariprazine (DDCAR) at steady state. •Determination of the exposure to Cariprazine (CAR), Desmethyl Cariprazine (DCAR) and Didesmethyl Cariprazine (DDCAR) at steady state (Day 28, Cmax, and AUC0-24) for each subgroup (age/dose). •Apparent oral clearance (CL/F) of CAR for each subgroup (age/dose) •T1/2 of CAR, DCAR, DDCAR, determined for each subgroup (age/dose), if applicable ;Timepoint(s) of evaluation of this end point: Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety assessments including UKU side effects rating scale, ECG, physical examination and clinical laboratory parameters, movement disorder scales (BARS, AIMS, SAS), Children’s Depression Rating Scale (CDRS) and Columbia Suicide Severity Rating Scale (C-SSRS) for assessment of depressive and suicidal symptoms.;Timepoint(s) of evaluation of this end point: Day 56 | — |
Countries
Bulgaria, Russian Federation
Contacts
Public ContactHerta Pálfi Goóts
Gedeon Richter Plc.
Outcome results
None listed