NCT00892125

A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder

Evaluation of the Effect of Carbamazepine on the Steady-state Pharmacokinetics of Paliperidone Extended Release in Clinically Stable Subjects With Schizophrenia or Bipolar I Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER and to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder.

Detailed description

The current study is designed as an open-label, multiple-center, multiple-dose, 2 treatment, 2 period sequential drug interaction study. It consists of 3 phases: a screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2), during which patients will receive multiple oral doses of 6-mg paliperidone ER alone or in combination with multiple oral doses of carbamazepine, and end of study evaluations upon completion of all the study procedures in Period 2 or at early withdrawal. There is no washout period between treatment periods. Given the potential concomitant use of carbamazepine with antipsychotics, such as paliperidone ER, in the treatment of schizophrenia or bipolar I disorder, this study is designed to investigate the effect of carbamazepine on the steady-state pharmacokinetics of paliperidone ER. Safety and tolerability will be monitored throughout the study.. Period 1: 6 mg paliperidone ER once daily from Day 1 through Day 7, route oral; Period 2: 6 mg paliperidone ER once daily and carbamazepine 200 mg twice daily from Day 8 through Day 28, route oral.

Conditions

• Schizophrenia
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	paliperidone ER; Carbamazepine

Timeline

• Start date: 2006-09-01
• Completion: 2007-03-01
• First posted: 2009-05-04
• Last updated: 2011-05-18