A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics

April 8, 2013 updated by: Janssen Research & Development, LLC

Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection

The purpose of this study is to compare capillary (the smallest of a body's blood vessels) and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single oral, immediate-release dose to healthy participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be treated at the same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Participants will enter the investigational site in the morning of Day -1 and stay until the morning of Day 2. Participants will return to the study site for subsequent assessments as per study's schedule. The total study length for a participant is approximately 26 days, except for participants receiving aripiprazole for whom the total study length is approximately 39 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (weight [kg]/height2 [m]2) between 17 and 35 kg/m2 (inclusive), and body weight not less than 50 kg
  • If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
  • If a woman, must have negative pregnancy test at screening
  • If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
  • Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

  • History of or current clinically significant medical illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for laboratorial tests
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen), oral contraceptives and hormonal replacement therapy, within 14 days before the study drug administration is scheduled
  • Positive test for alcohol or drugs of abuse at screening
  • Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A: Aripiprazole
Drug: Aripiprazole
Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast.
Experimental: Cohort B: Quetiapine
Drug: Quetiapine
Type= exact number, unit= mg, number= 100, form= tablet, route= oral administration. A single oral dose of two 50-mg quetiapine tablets will be administered after an overnight fast.
Experimental: Cohort C: Olanzapine
Drug: Olanzapine
Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast.
Experimental: Cohort D: Risperidone
Drug: Risperidone
Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast.
Experimental: Cohort E: Paliperidone
Drug: Paliperidone
Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 16 time points over 408 hours postdose
16 time points over 408 hours postdose
Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 12 time points over 108 hours postdose
12 time points over 108 hours postdose
Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 12 time points over 108 hours postdose
12 time points over 108 hours postdose
Risperidone concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 12 time points over 108 hours postdose
12 time points over 108 hours postdose
Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 12 time points over 108 hours postdose
12 time points over 108 hours postdose
Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 16 time points over 408 hours postdose
16 time points over 408 hours postdose
9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood
Time Frame: 12 time points over 108 hours postdose
12 time points over 108 hours postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse events as a measure of safety and tolerability
Time Frame: Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A)
Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100831
  • INDIGO-APS-1001 (Other Identifier: Janssen Research & Development, LLC)
  • 2011-006133-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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