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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01607762
First received: May 25, 2012
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Aripiprazole
Drug: Quetiapine
Drug: Olanzapine
Drug: Risperidone
Drug: Paliperidone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 16 time points over 408 hours postdose ] [ Designated as safety issue: No ]
  • Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 12 time points over 108 hours postdose ] [ Designated as safety issue: No ]
  • Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 12 time points over 108 hours postdose ] [ Designated as safety issue: No ]
  • Risperidone concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 12 time points over 108 hours postdose ] [ Designated as safety issue: No ]
  • Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 12 time points over 108 hours postdose ] [ Designated as safety issue: No ]
  • Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 16 time points over 408 hours postdose ] [ Designated as safety issue: No ]
  • 9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood [ Time Frame: 12 time points over 108 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607762

Locations
Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01607762     History of Changes
Other Study ID Numbers: CR100831, INDIGO-APS-1001, 2011-006133-41
Study First Received: May 25, 2012
Last Updated: April 8, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Janssen Research & Development, LLC:
Healthy
Antipsychotics
Aripiprazole
Paliperidone
Risperidone
Quetiapine
Olanzapine

Additional relevant MeSH terms:
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
9-hydroxy-risperidone
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 20, 2014