Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants
Condition: Psychotic Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to gather information about the steady-state plasma
      concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at
      various dose levels and at different time points after dosing. In addition, comparison of
      capillary drug concentrations vs. venous drug concentrations will be performed for
      aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant
      metabolites.
    

Detailed description: 
      This is an open-label (physicians and participants know the identity of the assigned
      treatment), parallel-group, multiple-dose, multicenter study to assess pharmacokinetics (what
      the body does to the medication) of five antipsychotics (APS) drugs: aripiprazole,
      olanzapine, paliperidone, quetiapine and risperidone in psychiatric participants who are
      receiving stable doses of these drugs for the treatment of their disease.

      Pharmacokinetics data will be generated from venous and fingerstick-based capillary plasma
      concentrations of the drugs and their metabolites. The total number of enrolled participants
      in this study will be at least 265. Seventy-five participants will be enrolled for the
      aripiprazole, olanzapine and quetiapine cohorts (groups) each, and 20 participants will be
      enrolled for the paliperidone and risperidone cohorts each. In aripiprazole, olanzapine and
      quetiapine cohorts there will be two subgroups. Subgroup one, 20 participants for fingerstick
      capillary + venous blood sampling and subgroup two, 55 participants for only venous sampling.
      Paliperidone and risperidone cohorts will be subjected only to capillary + venous blood
      sampling.

      The study will consist of a screening phase (within 21 days before Day 1) followed by a 3-day
      observation phase (Day 1 to Day 3). Participants will be admitted to the study center in the
      evening of Day -1 and will remain in the study center until discharged on Day 3 after
      completion of the last study-related procedure. During the observation phase, the
      administration of the prior antipsychotic medication will continue at a participant's usual
      dose and dosing schedule, under direct observation of the study staff. There will be no
      modification of the participant's medication during the study. Safety will be evaluated
      throughout the study and a mandatory pharmacogenomic blood sample will be collected for
      analysis of genes that may influence exposure of the APS studied.
    

Intervention name(s): Aripiprazole, oral formulation; Olanzapine, oral formulation; Paliperidone, oral formulation; Paliperidone, LAI; Quetiapine, oral formulation; Risperidone, oral formulation; Risperidone, LAI
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.; Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.; Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.; Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.; Quetiapine immediate-release (IR) formulation or extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.; Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.; Risperidone LAI injections will be administered will be administered per the locally approved label indications.
Other intervention name(s): INVEGA®; INVEGA®; RISPERDAL®; RISPERDAL®
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Psychotic Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder; Antipsychotics; Aripiprazole; Olanzapine; Paliperidone; Quetiapine; Risperidone; Capillary Concentration