A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
Condition: Schizophrenia; Hepatic Impairment
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate
      release (IR) paliperidone, after oral administration, in patients having moderate hepatic
      impairment compared to patients having normal hepatic function, 2) to document the plasma
      protein binding and disposition of the enantiomers of paliperidone, and 3) to evaluate the
      tolerability and safety profile of IR paliperidone in both patient populations.
    

Detailed description: 
      This is a single-dose, parallel-group, open-label, single-center, Phase 1 study of immediate
      release (IR) paliperidone in patients having either normal or moderately-impaired hepatic
      function. The groups, which will consist of 10 patients each, will be demographically matched
      with respect to age, weight, sex, and ethnicity. The study will consist of a screening period
      of up to 3 weeks and an open-label, single-dose treatment period (Days 1 through 5). On Day
      1, a single dose of 1 mg Intermediate Release (IR) paliperidone oral solution will be
      administered after a fast of at least 10 hours; patients will continue to fast for 4 hours
      following study drug administration. The 96-hour follow-up will consist of serial sample
      collections of blood and urine for pharmacokinetic analysis and safety and tolerability
      assessments. Patients will remain confined to the study site through the 72-hour
      pharmacokinetics sampling and will consume standard institutional meals while in the study
      site. Patients will be released after the 72-hour sampling, then will return to the study
      site on Day 5 before the 96-hour pharmacokinetics sampling; end-of-study procedures will be
      performed immediately thereafter. Currently, pharmacokinetic data are available after oral IR
      and Extended Release (ER) formulations of paliperidone were administered to healthy patients
      and to patients with schizophrenia who had normal hepatic function. No pharmacokinetic
      information on paliperidone in patients with hepatic impairment has been obtained. The target
      population for paliperidone comprises schizophrenic patients. Because some patients in the
      target population might be hepatically impaired, pharmacokinetic information in this
      population is helpful. This single-dose pharmacokinetic study will collect information in
      patients with normal hepatic function and in patients with moderate hepatic impairment to
      provide clinical dosing information/recommendations for patients with hepatic impairment.
      Safety and tolerability will be monitored. A single dose of 1 mg intermediate release (IR)
      paliperidone oral solution
    

Intervention name(s): Intermediate release (IR) Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mood disorders; Antipsychotic drugs; intermediate release (IR) Paliperidone