Psychotic DisordersPhase 1NCT02087579
Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants
A Phase 1 study testing Aripiprazole, oral formulation, Olanzapine, oral formulation and Paliperidone, oral formulation in people with Psychotic Disorders and Schizophrenia, run by Janssen Research & Development, LLC at 24 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
- What is being tested?
- Aripiprazole, oral formulation, Olanzapine, oral formulation and Paliperidone, oral formulation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 24 sitesin 7 countries
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States6 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Cedarhurst, New York
Study site
Garden Grove, California
Study site
Hoffman Estates, Illinois
Study site
Kissimmee, Florida
Argentina4 sites
Study site
Banfield
Study site
Buenos Aires
Study site
Córdoba
Study site
La Plata
Belgium4 sites
Study site
Aalst
Study site
Antwerp
Study site
Brussels
Study site
Kortenberg
Spain4 sites
Study site
Badajoz
Study site
Barcelona
Study site
Torrevieja
Study site
Zamora
About this study
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
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.
Read the 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.
- Being tested
- Aripiprazole, oral formulation, Olanzapine, oral formulation, Paliperidone, oral formulation, Paliperidone, LAI, Quetiapine, oral formulation
- Keywords
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Antipsychotics, Aripiprazole, Olanzapine, Paliperidone, Quetiapine, Risperidone, Capillary Concentration
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole, oral formulationDrug
Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.
Olanzapine, oral formulationDrug
Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.
Paliperidone, oral formulationDrug
Also called INVEGA®
Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
Paliperidone, LAIDrug
Also called INVEGA®
Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.
Quetiapine, oral formulationDrug
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 formulationDrug
Also called RISPERDAL®
Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
Risperidone, LAIDrug
Also called RISPERDAL®
Risperidone LAI injections will be administered will be administered per the locally approved label indications.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Aripiprazole | Experimental | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. Receives: Drug: Aripiprazole, oral formulation |
| Cohort B: Olanzapine | Experimental | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. Receives: Drug: Olanzapine, oral formulation |
| 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. Receives: Drug: Paliperidone, oral formulation; Drug: Paliperidone, LAI |
| Cohort D: Quetiapine | Experimental | Administration of oral formulation will continue at a participant's usual dose and dosing schedule. Receives: Drug: Quetiapine, oral formulation |
| Cohort E: Risperidone | Experimental | Administration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule. Receives: Drug: Risperidone, oral formulation; Drug: Risperidone, LAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aripiprazole concentration in venous and capillary plasma
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.
Measured: 14 time points over 3 days postdose
Paliperidone concentration in venous and capillary plasma
Measured: 14 time points over 3 days postdose
Olanzapine concentration in venous and capillary plasma
Measured: 14 time points over 3 days postdose
Quetiapine concentration in venous and capillary plasma
Measured: 14 time points over 3 days postdose
Risperidone concentration in venous and capillary plasma
Measured: 14 time points over 3 days postdose
Secondary outcomes (1)
Number of participants with an adverse event as a measure of safety
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087579
- Sponsor's protocol ID
- CR103695
- Other IDs
- 2013-005289-20, INDIGOAPS1003
- Status last verified
- Oct 2015
- First submitted
- 17 Feb 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02087579
- Acronym / sponsor ID
- CR103695
- Keywords
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder, Antipsychotics, Aripiprazole, Olanzapine, Paliperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Aripiprazole | Experimental | Drug: Aripiprazole, oral formulationAdministration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort B: Olanzapine | Experimental | Drug: Olanzapine, oral formulationAdministration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort C: Paliperidone | Experimental | Drug: Paliperidone, oral formulation, Drug: Paliperidone, LAIAdministration of prolonged-release (extended-release) tablets or long-acting injectables (LAI) will continue at a participant's usual dose and dosing schedule. |
| Cohort D: Quetiapine | Experimental | Drug: Quetiapine, oral formulationAdministration of oral formulation will continue at a participant's usual dose and dosing schedule. |
| Cohort E: Risperidone | Experimental | Drug: Risperidone, oral formulation, Drug: Risperidone, LAIAdministration of oral formulation or LAI will continue at a participant's usual dose and dosing schedule. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole, oral formulationAripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications. | Drug | Cohort A: Aripiprazole |
| Olanzapine, oral formulationOlanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications. | Drug | Cohort B: Olanzapine |
| Paliperidone, oral formulationAlso: INVEGA®Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications. | Drug | Cohort C: Paliperidone |
| Paliperidone, LAIAlso: INVEGA®Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications. | Drug | Cohort C: Paliperidone |
| Quetiapine, oral formulationQuetiapine 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 | Cohort D: Quetiapine |
| Risperidone, oral formulationAlso: RISPERDAL®Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications. | Drug | Cohort E: Risperidone |
| Risperidone, LAIAlso: RISPERDAL®Risperidone LAI injections will be administered will be administered per the locally approved label indications. | Drug | Cohort E: Risperidone |
Primary outcome
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.
Paliperidone concentration in venous and capillary plasma
Time frame: 14 time points over 3 days postdose
Olanzapine concentration in venous and capillary plasma
Time frame: 14 time points over 3 days postdose
Quetiapine concentration in venous and capillary plasma
Time frame: 14 time points over 3 days postdose
Risperidone concentration in venous and capillary plasma
Time frame: 14 time points over 3 days postdose
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of 5 Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and RisperidoneLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aripiprazole, oral formulation, Olanzapine, oral formulation and Paliperidone, oral formulation in people with Psychotic Disorders and Schizophrenia, run by Janssen Research & Development, LLC at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Argentina, Belgium, Spain, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aripiprazole concentration in venous and capillary plasma (time frame: 14 time points over 3 days postdose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.