Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to gather information about the steady-state plasma concentrations of aripiprazole, olanzapine, quetiapine and their relevant metabolites, at various dose levels and at different time points after dosing. In addition, comparison of capillary drug concentrations vs. venous drug concentrations will be performed for aripiprazole, olanzapine, paliperidone, quetiapine, risperidone and their relevant metabolites.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Must be clinically stable as per the investigator's judgment (no suicidal behavior or current significant suicidal judgment based on C-SSRS rating scale)

• No hospitalization for exacerbation of psychiatric symptoms during 3 months before screening

• Receiving treatment with aripiprazole, olanzapine, paliperidone, quetiapine or risperidone, or their combination before the study

• Must have body mass index between 17 and 40 kg/m2 (inclusive), and body weight not less than 47 kg

• Except for the indication for which the antipsychotic treatment is given, generally healthy with no clinically significant or unstable medical problems

• Must be able to give informed consent

Exclusion Criteria:

• Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening as determined by the investigator

• Administering of strong inhibitors or inducers of CYP3A4, CYP2D6 enzymes, like fluoxetine

• History of or current clinically significant (particularly unstable) medical illness other than the indication

• Donated blood or blood products or had substantial loss of blood (more than 450 mL) within 3 months before Day -1

• Lack of 6 suitable puncture sites for capillary blood draws