Schizophrenia Clinical Trial
Official title:
Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of Five Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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