NCT02087579

Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants

Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of Five Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychotic Disorders
• Schizophrenia
• Bipolar Disorder
• Depressive Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole, oral formulation	Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.
DRUG	Olanzapine, oral formulation	Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.
DRUG	Paliperidone, oral formulation	Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
DRUG	Paliperidone, LAI	Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.
DRUG	Quetiapine, oral formulation	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.
DRUG	Risperidone, oral formulation	Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
DRUG	Risperidone, LAI	Risperidone LAI injections will be administered will be administered per the locally approved label indications.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-03-14
• Last updated: 2015-10-29

Locations

24 sites across 7 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Germany, Spain