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

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ClinicalTrials.gov Identifier: NCT02087579
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Schizophrenia Bipolar Disorder Depressive Disorder Drug: Aripiprazole, oral formulation Drug: Olanzapine, oral formulation Drug: Paliperidone, oral formulation Drug: Paliperidone, LAI Drug: Quetiapine, oral formulation Drug: Risperidone, oral formulation Drug: Risperidone, LAI Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : February 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A: Aripiprazole
Administration of oral formulation will continue at a participant's usual dose and dosing schedule.
Drug: Aripiprazole, oral formulation
Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.

Experimental: Cohort B: Olanzapine
Administration of oral formulation will continue at a participant's usual dose and dosing schedule.
Drug: Olanzapine, oral formulation
Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.

Experimental: Cohort C: Paliperidone
Administration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule.
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.
Other Name: INVEGA®

Drug: Paliperidone, LAI
Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.
Other Name: INVEGA®

Experimental: Cohort D: Quetiapine
Administration of oral formulation will continue at a participant's usual dose and dosing schedule.
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.

Experimental: Cohort E: Risperidone
Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule.
Drug: Risperidone, oral formulation
Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
Other Name: RISPERDAL®

Drug: Risperidone, LAI
Risperidone LAI injections will be administered will be administered per the locally approved label indications.
Other Name: RISPERDAL®




Primary Outcome Measures :
  1. Aripiprazole concentration in venous and capillary plasma [ Time Frame: 14 time points over 3 days postdose ]
    Venous blood samples will be collected at 8 scheduled time points after dosing and compared to fingerstick-based capillary blood samples collected at 6 scheduled time points after dosing.

  2. Paliperidone concentration in venous and capillary plasma [ Time Frame: 14 time points over 3 days postdose ]
  3. Olanzapine concentration in venous and capillary plasma [ Time Frame: 14 time points over 3 days postdose ]
  4. Quetiapine concentration in venous and capillary plasma [ Time Frame: 14 time points over 3 days postdose ]
  5. Risperidone concentration in venous and capillary plasma [ Time Frame: 14 time points over 3 days postdose ]

Secondary Outcome Measures :
  1. Number of participants with an adverse event as a measure of safety [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087579


Locations
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United States, California
Garden Grove, California, United States
United States, Florida
Kissimmee, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Hoffman Estates, Illinois, United States
United States, New York
Cedarhurst, New York, United States
United States, Texas
Austin, Texas, United States
Argentina
Banfield, Argentina
Ciudad Autónoma De Buenos Aires, Argentina
Cordoba, Argentina
La Plata, Argentina
Belgium
Aalst, Belgium
Antwerpen, Belgium
Brussel, Belgium
Kortenberg, Belgium
Brazil
Rio De Janeiro, Brazil
Valinhos, Brazil
Bulgaria
Bourgas, Bulgaria
Germany
Berlin, Germany
Hamburg, Germany
Luebeck, Germany
Spain
Badajoz, Spain
Barcelona, Spain
Torrevieja, Spain
Zamora, Spain
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02087579     History of Changes
Other Study ID Numbers: CR103695
2013-005289-20 ( EudraCT Number )
INDIGOAPS1003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Janssen Research & Development, LLC:
Depressive Disorder
Psychotic Disorders
Schizophrenia
Bipolar Disorder
Antipsychotics
Aripiprazole
Olanzapine
Paliperidone
Quetiapine
Risperidone
Capillary Concentration
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Behavioral Symptoms
Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Bipolar and Related Disorders
Olanzapine
Risperidone
Antipsychotic Agents
Aripiprazole
Quetiapine Fumarate
Paliperidone Palmitate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists