Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants
NCT ID: NCT02087579
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
305 participants
INTERVENTIONAL
2014-02-28
2014-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cohort A: Aripiprazole
Administration of oral formulation will continue at a participant's usual dose and dosing schedule.
Aripiprazole, oral formulation
Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.
Cohort B: Olanzapine
Administration of oral formulation will continue at a participant's usual dose and dosing schedule.
Olanzapine, oral formulation
Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.
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.
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.
Paliperidone, LAI
Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.
Cohort D: Quetiapine
Administration of oral formulation will continue at a participant's usual dose and dosing schedule.
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.
Cohort E: Risperidone
Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule.
Risperidone, oral formulation
Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
Risperidone, LAI
Risperidone LAI injections will be administered will be administered per the locally approved label indications.
Interventions
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Aripiprazole, oral formulation
Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.
Olanzapine, oral formulation
Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.
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.
Paliperidone, LAI
Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.
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.
Risperidone, oral formulation
Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
Risperidone, LAI
Risperidone LAI injections will be administered will be administered per the locally approved label indications.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Garden Grove, California, United States
Kissimmee, Florida, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Cedarhurst, New York, United States
Austin, Texas, United States
Banfield, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Aalst, , Belgium
Antwerp, , Belgium
Brussels, , Belgium
Kortenberg, , Belgium
Rio de Janeiro, , Brazil
Valinhos, , Brazil
Burgas, , Bulgaria
Berlin, , Germany
Hamburg, , Germany
Lübeck, , Germany
Badajoz, , Spain
Barcelona, , Spain
Torrevieja, , Spain
Zamora, , Spain
Countries
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Related Links
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Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of 5 Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone
Other Identifiers
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2013-005289-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INDIGOAPS1003
Identifier Type: OTHER
Identifier Source: secondary_id
CR103695
Identifier Type: -
Identifier Source: org_study_id
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