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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00791401 |
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg extended release paliperidone (ER OROSÒ paliperidone) in patients with varying degrees of renal impairment (mild, moderate, and severe), compared to patients with normal renal function. Secondary objectives include the assessing the disposition of the (+) and (-) enantiomers by means of an enantioselective liquid chromatography mass spectrometry assay, to determine plasma protein binding of the enantiomers in patients with impaired renal function, compared with patients with normal renal function, and to evaluate the tolerability and safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment (mild, moderate, and severe) compared with patients with normal renal function.
Condition | Intervention | Phase |
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Schizophrenia Renal Impairment |
Drug: ER OROS Paliperidone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | The Pharmacokinetics of ER OROS Paliperidone in Subjects With Varying Degrees of Impaired Renal Function (Mild, Moderate, and Severe) as Compared to Subjects With Normal Renal Function |
Estimated Enrollment: | 48 |
Study Start Date: | April 2004 |
Study Completion Date: | February 2005 |
This is a single dose, parallel group, open-label, 2 center pharmacokinetic study, consisting of a pretreatment (screening) period of between 1 and 3 weeks, an open label treatment period (single dose of ER OROS paliperidone on Day 1 only, and with end of study procedures and discharge ending on Day 6). All patients will be screened between Day 21 and Day -1 for renal function. On Day 1, all patients will receive a single oral dose of 3 mg ER OROS paliperidone and undergo a 120 hour follow up with serial blood collections for pharmacokinetics, safety and tolerability assessments. Patients will be discharged after giving a pharmacokinetic blood sample and completing end of study assessments in the morning of Day 6. Group matching will be applied to the renal function groups to reduce bias and increase comparability of age, weight, gender, and ethnicity. This study is aimed to compare the pharmacokinetics and safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment with that of normal patients.
3 mg oral ER OROS paliperidone
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004207 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00791401 |
Health Authority: | United States: Food and Drug Administration |
Antipsychotic drugs Mood disorders ER OROS Paliperidone Schizophrenia |
Schizophrenia Mental Disorders Risperidone Mood Disorders |
9-hydroxy-risperidone Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |