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

Janssen Research & Development, LLC0 sites305 target enrollmentStarted: February 2014Last updated: October 29, 2015

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Janssen Research & Development, LLC
Enrollment: 305
Primary Endpoint: Olanzapine concentration in venous and capillary plasma

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Parallel
Primary Purpose: Basic Science
Masking: None

Eligibility Criteria

Ages: 18 Years to 70 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Must be clinically stable as per the investigator's judgment (no suicidal behavior or current significant suicidal judgment based on C-SSRS rating scale)
•No hospitalization for exacerbation of psychiatric symptoms during 3 months before screening
•Receiving treatment with aripiprazole, olanzapine, paliperidone, quetiapine or risperidone, or their combination before the study
•Must have body mass index between 17 and 40 kg/m2 (inclusive), and body weight not less than 47 kg
•Except for the indication for which the antipsychotic treatment is given, generally healthy with no clinically significant or unstable medical problems
•Must be able to give informed consent

Exclusion Criteria

•Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening as determined by the investigator
•Administering of strong inhibitors or inducers of CYP3A4, CYP2D6 enzymes, like fluoxetine
•History of or current clinically significant (particularly unstable) medical illness other than the indication
•Donated blood or blood products or had substantial loss of blood (more than 450 mL) within 3 months before Day -1
•Lack of 6 suitable puncture sites for capillary blood draws

Arms & Interventions

Cohort A: Aripiprazole

Experimental

Administration of oral formulation will continue at a participant's usual dose and dosing schedule.

Intervention: Aripiprazole, oral formulation (Drug)

Cohort B: Olanzapine

Experimental

Administration of oral formulation will continue at a participant's usual dose and dosing schedule.

Intervention: Olanzapine, oral formulation (Drug)

Cohort C: Paliperidone

Experimental

Administration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule.

Intervention: Paliperidone, oral formulation (Drug)

Cohort C: Paliperidone

Experimental

Administration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule.

Intervention: Paliperidone, LAI (Drug)

Cohort D: Quetiapine

Experimental

Administration of oral formulation will continue at a participant's usual dose and dosing schedule.

Intervention: Quetiapine, oral formulation (Drug)

Cohort E: Risperidone

Experimental

Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule.

Intervention: Risperidone, oral formulation (Drug)

Cohort E: Risperidone

Experimental

Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule.

Intervention: Risperidone, LAI (Drug)