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

NCT01607762 | Completed Phase 1

• 3 other identifiers: CR100831INDIGO-APS-10012011-006133-41
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; Antipsychotics; Aripiprazole; Paliperidone; Risperidone; Quetiapine; Olanzapine

Outcome Measures

Primary Outcomes (7)

• Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood

  16 time points over 408 hours postdose

• Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood

  12 time points over 108 hours postdose

• Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood

  12 time points over 108 hours postdose

• Risperidone concentration in venous and capillary plasma, venous and capillary whole blood

  12 time points over 108 hours postdose

• Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood

  12 time points over 108 hours postdose

• Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood

  16 time points over 408 hours postdose

• 9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood

  12 time points over 108 hours postdose

Secondary Outcomes (1)

• Incidence of adverse events as a measure of safety and tolerability

  Approximately 26 days (Cohorts B, C, D, E), and approximately 39 days (Cohort A)

Study Arms (5)

Cohort A: Aripiprazole

EXPERIMENTAL

Drug: Aripiprazole

Cohort B: Quetiapine

EXPERIMENTAL

Drug: Quetiapine

Cohort C: Olanzapine

EXPERIMENTAL

Drug: Olanzapine

Cohort D: Risperidone

EXPERIMENTAL

Drug: Risperidone

Cohort E: Paliperidone

EXPERIMENTAL

Drug: Paliperidone

Interventions

Aripiprazole DRUG

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.

Cohort A: Aripiprazole

Quetiapine DRUG

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.

Cohort B: Quetiapine

Olanzapine DRUG

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.

Cohort C: Olanzapine

Risperidone DRUG

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.

Cohort D: Risperidone

Paliperidone DRUG

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.

Cohort E: Paliperidone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Aripiprazole; Quetiapine Fumarate; Olanzapine; Risperidone; Paliperidone Palmitate

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Benzodiazepines; Benzazepines; Pyrimidinones; Pyrimidines; Isoxazoles; Azoles

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 30, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

BE (1)