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

Completed · Phase 1

Conditions studied: Psychotic Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder

In brief

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.

Key facts

Study ID

NCT02087579

Run by

Janssen Research & Development, LLC

People needed

305

Starts

2014-02-01

Expected to finish

2014-12-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Garden Grove, California, United States
• Study site — Kissimmee, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Hoffman Estates, Illinois, United States
• Study site — Cedarhurst, New York, United States
• Study site — Austin, Texas, United States
• Study site — Banfield, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — La Plata, Argentina
• Study site — Aalst, Belgium
• Study site — Antwerp, Belgium
• Study site — Brussels, Belgium
• Study site — Kortenberg, Belgium
• Study site — Rio de Janeiro, Brazil
• Study site — Valinhos, Brazil
• Study site — Burgas, Bulgaria
• Study site — Berlin, Germany
• Study site — Hamburg, Germany
• Study site — Lübeck, Germany
• Study site — Badajoz, Spain
• Study site — Barcelona, Spain
• Study site — Torrevieja, Spain
• Study site — Zamora, Spain

Full record on ClinicalTrials.gov

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