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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aripiprazole; Drug: Quetiapine; Drug: Olanzapine; Drug: Risperidone; Drug: Paliperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01607762

CR100831

2011-006133-41 (EudraCT Number)

INDIGO-APS-1001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 5 patient groups

Cohort A: Aripiprazole

Experimental group

Treatment:

Drug: Aripiprazole

Cohort B: Quetiapine

Experimental group

Treatment:

Drug: Quetiapine

Cohort C: Olanzapine

Experimental group

Treatment:

Drug: Olanzapine

Cohort D: Risperidone

Experimental group

Treatment:

Drug: Risperidone

Cohort E: Paliperidone

Experimental group

Treatment:

Drug: Paliperidone