NCT02087579

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2014

Geographic Reach
7 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

February 17, 2014

Last Update Submit

October 28, 2015

Conditions

Psychotic DisordersSchizophreniaBipolar DisorderDepressive Disorder

Keywords

Psychotic DisordersSchizophreniaBipolar DisorderDepressive DisorderAntipsychoticsAripiprazoleOlanzapinePaliperidoneQuetiapineRisperidoneCapillary Concentration

Outcome Measures

Primary Outcomes (5)

  • 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.

    14 time points over 3 days postdose

  • Paliperidone concentration in venous and capillary plasma

    14 time points over 3 days postdose

  • Olanzapine concentration in venous and capillary plasma

    14 time points over 3 days postdose

  • Quetiapine concentration in venous and capillary plasma

    14 time points over 3 days postdose

  • Risperidone concentration in venous and capillary plasma

    14 time points over 3 days postdose

Secondary Outcomes (1)

  • Number of participants with an adverse event as a measure of safety

    Participants will be followed for the duration of hospital stay, an expected average of 3 days

Study Arms (5)

Cohort A: Aripiprazole

EXPERIMENTAL

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

Drug: Aripiprazole, oral formulation

Cohort B: Olanzapine

EXPERIMENTAL

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

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.

Drug: Paliperidone, oral formulationDrug: Paliperidone, LAI

Cohort D: Quetiapine

EXPERIMENTAL

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

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.

Drug: Risperidone, oral formulationDrug: Risperidone, LAI

Interventions

Aripiprazole, oral formulationDRUG

Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.

Cohort A: Aripiprazole
Olanzapine, oral formulationDRUG

Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.

Cohort B: Olanzapine
Paliperidone, oral formulationDRUG

Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

Also known as: INVEGA®
Cohort C: Paliperidone
Paliperidone, LAIDRUG

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

Also known as: INVEGA®
Cohort C: Paliperidone
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.

Cohort D: Quetiapine
Risperidone, oral formulationDRUG

Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.

Also known as: RISPERDAL®
Cohort E: Risperidone
Risperidone, LAIDRUG

Risperidone LAI injections will be administered will be administered per the locally approved label indications.

Also known as: RISPERDAL®
Cohort E: Risperidone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Unknown Facility

Garden Grove, California, United States

Location

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Hoffman Estates, Illinois, United States

Location

Unknown Facility

Cedarhurst, New York, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Banfield, Argentina

Location

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Córdoba, Argentina

Location

Unknown Facility

La Plata, Argentina

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Kortenberg, Belgium

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Valinhos, Brazil

Location

Unknown Facility

Burgas, Bulgaria

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Lübeck, Germany

Location

Unknown Facility

Badajoz, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Torrevieja, Spain

Location

Unknown Facility

Zamora, Spain

Location

Related Links

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaBipolar DisorderDepressive Disorder

Interventions

AripiprazoleDosage FormsOlanzapinePaliperidone PalmitateQuetiapine FumarateRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesBenzodiazepinesBenzazepinesIsoxazolesAzolesPyrimidinesDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingPyrimidinones

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

March 14, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

US(6)ES(4)BR(2)BU(1)AR(4)BE(4)DE(3)