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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607762
• Other study ID #: CR100831
• Secondary ID: INDIGO-APS-10012
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2012
• Last updated: April 8, 2013
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aripiprazole concentration in venous and capillary plasma, venous and capillary whole blood		16 time points over 408 hours postdose	No
Primary	Quetiapine concentration in venous and capillary plasma, venous and capillary whole blood		12 time points over 108 hours postdose	No
Primary	Olanzapine concentration in venous and capillary plasma, venous and capillary whole blood		12 time points over 108 hours postdose	No
Primary	Risperidone concentration in venous and capillary plasma, venous and capillary whole blood		12 time points over 108 hours postdose	No
Primary	Paliperidone concentration in venous and capillary plasma, venous and capillary whole blood		12 time points over 108 hours postdose	No
Primary	Dehydroaripiprazole concentration in venous and capillary plasma, venous and capillary whole blood		16 time points over 408 hours postdose	No
Primary	9 hydroxy-risperidone concentration in venous and capillary plasma, venous and capillary whole blood		12 time points over 108 hours postdose	No
Secondary	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)	No