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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Paliperidone Palmitate; Quetiapine Fumarate; Risperidone

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)