A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the concentration of paliperidone in the blood after
      intramuscular injection in upper arm (deltoid muscle) or in the buttock (gluteal muscle) in
      patients with schizophrenia.
    

Detailed description: 
      This is a an open-label (all patients will know the name of the study drug that they are
      receiving), randomized (patients will selected by "chance" or like "flipping a coin" to
      administration of study drug by intramuscular [i.m.] injection into the gluteal [buttocks] or
      deltoid [upper arm] muscle of the body) study in patients with schizophrenia. A minimum of 40
      patients (20 patients per group [1 group of patients to be administered study drug by
      injection in the gluteal muscle and 1 group of patients to be administered study drug by
      injection in the deltoid muscle]) will participate in this study, including at least 4 women
      in each group. The study will consist of a screening period that will occur within 21 days
      before the first study drug administration, an open-label treatment period during which
      patients will receive a total of 4 injections of study drug (paliperidone palmitate) either
      in the deltoid or gluteal muscle, and an end-of-study visit where final study evaluations
      will be performed. At the screening visit, if a patient has been treated with an
      antipsychotic medication before study entry, the medication may be continued during the study
      except for medications specified in the exclusion criteria for the study. If patients have
      not been previously treated with 1 of the following antipsychotic drugs: risperidone,
      paliperidone, or paliperidone palmitate, they will undergo a 4-day evaluation period where
      they will be given a 3 mg/day dose of an extended release (ER) formulation of paliperidone to
      evaluate their ability to tolerate study drug. Patients who meet all entry criteria for the
      study will be randomly assigned to 1 of 2 treatment groups in which they will receive 100 mg
      equivalent of paliperidone palmitate by i.m. injection in either the gluteal muscle or the
      deltoid muscle. Blood samples for pharmacokinetics (ie, to test the concentration of study
      drug in the blood) will be collected at specified times before and after each dose of study
      drug. A single blood sample may also be collected at any time during screening or before the
      first day of i.m. administration of study drug for patients who agree to participate in an
      optional part of the study called a pharmacogenomic evaluation which is an evaluation where
      genetic information obtained from the patient's blood is used to predict whether or not study
      drug will help make the patient well. During the study, the patient's psychiatric symptoms,
      severity of symptoms, and injection site reactions will be evaluated. The primary outcome
      measure in the study will be the determination of the concentration of paliperidone in the
      patient's blood before study drug administration at protocol-specified time points during the
      study. The patient's safety will be monitored throughout the study by performing physical
      examinations, vital signs measurements, clinical laboratory tests, electrocardiograms (ECGs),
      monitoring of extrapyramidal symptoms (ie, symptoms that can be associated with taking
      antipsychotic medications), injection site evaluations, and recording of adverse events (side
      effects). Each patient will receive a total of 4 paliperidone palmitate 100 mg equivalent
      injections in the gluteal or deltoid muscle on Day 1, 8, 36, and 64.
    

Intervention name(s): paliperidone palmitate 100 mg
Intervention type(s): Drug
Intervention description(s): Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1, 8, 36, and 64.
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone palmitate; R092670PSY1001; Pharmacokinetics; Risperdal (CONSTA); Risperidone, Paliperidone