A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function

NCT00791401 | Completed Phase 1

• 1 other identifier: CR004207
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg extended release paliperidone (ER OROSÃ' 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.

Conditions

Schizophrenia; Renal Impairment

Keywords

Schizophrenia; Mood disorders; Antipsychotic drugs; ER OROS Paliperidone

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics of a single oral dose of 3 mg ER OROS paliperidone in patients with varying degrees of renal impairment (mild, moderate, and severe), compared with patients with normal renal function

Secondary Outcomes (1)

• To assess the disposition of the (+) and (-) enantiomers, to determine plasma protein binding of the enantiomers, and to evaluate the tolerability and safety profile of ER OROS paliperidone in patients with renal impairment

Interventions

ER OROS Paliperidone DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients: A body mass index (weight \[kg\]/height (m)²) in the range of 18.0 to 32.0 kg/m², inclusive
• Patients with normal renal function: Healthy on the basis of a prestudy physical examination, medical history, 12-lead electrocardiogram (ECG), and blood hematology and biochemistry tests, and urinalysis carried out within 3 weeks before study drug is administered. Normal renal function
• Age-related normotensive at screening, with supine (5 minutes) blood pressure in the range of 95 to 160 mmHg systolic, inclusive, and 55 to 95 mmHg diastolic, inclusive, at screening and before study drug administration
• Demographically comparable to the groups with renal impairment with respect to age (±10 years), weight (±20%), gender, and ethnicity
• Patients with impaired renal function: Has a CrCl of \<80 mL/min
• Severity of renal disease has to be stable: No significant change in renal function as evidenced by the serum creatinine value within ±20% from the last determination, obtained within at least 2 months before study entry
• Is on stable dose of medication and/or treatment regimen for renal impairment from 2 months before the study. Patients with stable cardiovascular disease including hypertension controlled with a stable dose of medication for at least 2 months before enrollment, provided that the investigator feels their condition will not interfere with the results of the study. Patients with abnormal ECG changes considered by the investigator to be insignificant or clinically compatible with the patients's renal impairment may be included
• Patients on a stable dose of thyroid hormone replacement therapy, for at least 3 months before enrollment, may be enrolled, provided that the patients' condition will not interfere with the results of the study
• Patients with mild, stable, chronic degenerative joint disease may be enrolled
• Patients on concomitant medications to treat underlying disease states or medical conditions related to renal insufficiency may be enrolled into the study, except when specifically excluded by name or pharmacological class.

You may not qualify if:

• Patients with normal renal function: Has any significant history or presence of hematologic, gastrointestinal, renal, hepatic, cardiovascular, pulmonary, metabolic, neurologic, or psychiatric disease, has a relevant history of drug allergy, has a history of congenital or hereditary kidney disease (including polycystic kidney disease), has a history of nephrectomy
• Used any prescription or nonprescription medication (herbal supplements included) within 21 days before administration of study drug except for paracetamol (acetaminophen), hormonal contraceptives, and replacement therapy
• Patients with impaired renal function:Is in end stage renal disease, requiring dialysis, has an acute unstable and/or significant and untreated medical illness (e.g., infection, unstable angina), has any abnormality in medical history, physical examination, ECG, or laboratory results that, in the opinion of the investigator, may affect the safety of the patient (e.g., myocardial infarction, conduction defects \[e.g., QTc interval \>450 msec for men, \>470 msec for women\], atrial or ventricular arrhythmia, coronary artery disease, congestive heart failure, valvular diseases, peripheral vascular disorders, stroke, hematologic, pulmonary, neurologic, hepatic, psychiatric, metabolic or endocrine disturbances, or inadequate nutritional status, has a history of uric acid stone disease (in the last 5 years with recurrences), uricosuria, or current hyperuricemia serum uric acid \>=10 mg/dL, has uncontrolled Type 1 or 2 diabetes, has or had a renal transplant, systemic lupus erythematosus, or renal carcinoma, or has moderate to severe uncontrolled hypertension, defined as DBP \>=105 mmHg and/or SBP \>=180 mmHg (patients with stable mild hypertension controlled by a constant regimen over the last 2 months may be enrolled).

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study of the pharmacokinetics of ER OROS paliperidone in volunteers with normal or impaired renal function

MeSH Terms

Conditions

Schizophrenia; Renal Insufficiency; Mood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: April 1, 2004
• Study Completion: February 1, 2005
• Last Updated: June 13, 2011

Record last verified: 2010-03