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

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.

Conditions

• Psychotic Disorders
• Schizophrenia
• Bipolar Disorder
• Depressive Disorder

Interventions

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.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2014-10-31

Completion

2014-12-31

Countries

• United States
• Argentina
• Belgium
• Brazil
• Bulgaria
• Germany
• Spain

Study Locations