SchizophreniaPhase 1NCT00791401
A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function
A Phase 1 study testing ER OROS Paliperidone in people with Schizophrenia and Renal Impairment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Renal Impairment
- What is being tested?
- ER OROS Paliperidone
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Feb 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
About this 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
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.
Read the detailed description
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
- Conditions
- Schizophrenia, Renal Impairment
- Being tested
- ER OROS Paliperidone
- Keywords
- Schizophrenia, Mood disorders, Antipsychotic drugs, ER OROS Paliperidone
- Medical subject headings
- Schizophrenia, Renal Insufficiency, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER OROS PaliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startApr 2004
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791401
- Sponsor's protocol ID
- CR004207
- Status last verified
- Mar 2010
- First submitted
- 13 Nov 2008
- Last updated
- 13 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00791401
- Acronym / sponsor ID
- CR004207
- Conditions
- Schizophrenia, Renal Impairment
- Keywords
- Schizophrenia, Mood disorders, Antipsychotic drugs, ER OROS Paliperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Feb 2005 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ER OROS Paliperidone | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
- A study of the pharmacokinetics of ER OROS paliperidone in volunteers with normal or impaired renal functionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ER OROS Paliperidone in people with Schizophrenia and Renal Impairment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.