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As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Paliperidone ER

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Mood Disorders, Antipsychotic drugs, Paliperidone ER

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Currently treated with a dose of at least 6 mg of risperidone daily or the equivalent of any other antipsychotic medication or a combination thereof (an equivalence table will be provided to the sites)
Has a DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) or schizoaffective disorder
Healthy on the basis of a prestudy physical exam, medical history, ECG, and laboratory results of blood biochemistry, hematology, and urinalysis performed within 2 weeks of randomization. If the results of the biochemistry or hematology tests or the urinalysis are not within the laboratory's reference ranges the patient can be included only if the investigator judges that the deviations are not clinically significant. For liver function tests (alanine transaminase, aspartate transaminase, and bilirubin), the values must be contained within 2 times the upper limits of the normal laboratory reference ranges and for renal function tests, the values must be within the normal laboratory reference ranges
Women must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization and at the discretion of the investigator, total abstinence) before entry and throughout the study, as well as have a negative serum pregnancy test at screening. To ensure continued eligibility, women must have a negative urine test at baseline
Body weight as defined by body mass index (weight [kg]/height (m)²) within a range of 15.0 to 35.0 kg/m², inclusive
Willingness to spend 15 days as an in-patient during the treatment period
Normotensive at screening, with supine (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive.

Exclusion Criteria:

Involuntarily committed in-patients
Has a DSM-IV diagnosis of substance dependence within 3 months before screening evaluation. Nicotine and caffeine dependence and history of recreational use of marijuana are not exclusionary
At screening, has a decrease of > = 20 mmHg systolic blood pressure or a decrease of > =10 mmHg decrease in diastolic blood pressure 2 minutes after standing, or experience symptoms of lightheadedness, dizziness, or fainting upon standing
orthostatic hypotension
Tests positive for the urine drug screen at screening
Had an acute exacerbation of psychotic symptoms within the last 3 months before screen
Relevant history or current presence of any cardiovascular, respiratory, central nervous system, neuropsychiatric (including seizures), renal, hepatic, endocrine, or immunologic diseases
Has a DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder
Suicidal or homicidal ideation

Sites / Locations

Outcomes

Primary Outcome Measures

To compare the steady-state pharmacokinetics of paliperidone after administration of ER OROS paliperidone at 15 mg orally and IR risperidone at 8 mg orally, twice daily; to explore the dose-proportionality of 9 mg and 15 mg paliperidone ER

Secondary Outcome Measures

To document the disposition of the enantiomers of paliperidone, to explore the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and pharmacokinetic parameters, and to assess safety and tolerability

Full Information

NCT ID

NCT00796185

First Posted

November 20, 2008

Last Updated

June 6, 2011

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00796185

Brief Title

As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations

Official Title

Comparison of Steady-state Pharmacokinetics of Paliperidone After Extended-release OROS� Paliperidone 15 mg and Immediate-release Oral Risperidone 8 mg b.i.d. in Subjects With Schizophrenia or Schizoaffective Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to compare the steady-state pharmacokinetics of paliperidone after oral administration of 15 mg extended-release (ER) OROS paliperidone once daily with the steady-state pharmacokinetics of paliperidone after oral administration of 8 mg immediate-release (IR) risperidone twice daily; and to explore the dose-proportionality of 9 mg and 15 mg ER OROS paliperidone. Other objectives are to 1) document the disposition of the enantiomers of paliperidone; 2) explore the relationship between genotype (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and pharmacokinetic parameters; and 3) assess safety and tolerability.

Detailed Description

This is an open-label, multiple-dose, parallel-group study in patients with schizophrenia or schizoaffective disorder. The study consists of a screening period (2 weeks maximum); a 1-week run-in or washout (Days 1 to 7) during which patients taking risperidone prestudy and randomly assigned to paliperidone treatment will receive replacement antipsychotic therapy, and other patients continue to take their prestudy antipsychotic medication; a 14-day open-label treatment period (Days 8 to 21); and a 5-day follow-up period. On Day 1 of the washout period, eligible patients will be randomized to receive ER OROS paliperidone (PAL) or risperidone (RIS). All patients will receive their first dose of study medication on Day 8 after randomization as follows: Patients randomized to PAL will receive 9 mg of ER OROS paliperidone daily from Day 8 to Day 14, followed by 15 mg of ER OROS paliperidone q.d. from Day 15 to Day 21. Patients randomized to RIS will receive dose-escalation up to 7 mg risperidone twice daily (b.i.d.) from Day 8 to Day 14, followed by 8 mg risperidone b.i.d. from Day 15 to Day 21. The study medication on Days 14 and 21 in the PAL group and on Day 21 in the RIS group will be administered after completion of a standardized high fat, high caloric breakfast. Patients will be confined to the testing facility from the morning of Day 8 (or earlier at the discretion of the investigator) until completion of the study procedures on Day 23. On all other assessment days, patients will return to the testing facility and remain there for the duration of the assessments.The highest dose of paliperidone currently being studied is 12 mg given as 6 tablets of 2 mg ER OROS paliperidone. In the currently proposed study, data on the safety and tolerability of the 15-mg dose will be monitored and collected. Paliperidone ER oral administration of 9 mg q.d. on Day 8 to 14, and 15 mg daily on Day 15 to 21; oral administration of escalating doses up to 7 mg risperidone twice daily (b.i.d.) between Days 8 and 14, inclusive, and 8 mg risperidone b.i.d. on Day 15 to 21

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

Keywords

Schizophrenia, Schizoaffective Disorder, Mood Disorders, Antipsychotic drugs, Paliperidone ER

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Paliperidone ER

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Currently treated with a dose of at least 6 mg of risperidone daily or the equivalent of any other antipsychotic medication or a combination thereof (an equivalence table will be provided to the sites) Has a DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) or schizoaffective disorder Healthy on the basis of a prestudy physical exam, medical history, ECG, and laboratory results of blood biochemistry, hematology, and urinalysis performed within 2 weeks of randomization. If the results of the biochemistry or hematology tests or the urinalysis are not within the laboratory's reference ranges the patient can be included only if the investigator judges that the deviations are not clinically significant. For liver function tests (alanine transaminase, aspartate transaminase, and bilirubin), the values must be contained within 2 times the upper limits of the normal laboratory reference ranges and for renal function tests, the values must be within the normal laboratory reference ranges Women must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization and at the discretion of the investigator, total abstinence) before entry and throughout the study, as well as have a negative serum pregnancy test at screening. To ensure continued eligibility, women must have a negative urine test at baseline Body weight as defined by body mass index (weight [kg]/height (m)²) within a range of 15.0 to 35.0 kg/m², inclusive Willingness to spend 15 days as an in-patient during the treatment period Normotensive at screening, with supine (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive. Exclusion Criteria: Involuntarily committed in-patients Has a DSM-IV diagnosis of substance dependence within 3 months before screening evaluation. Nicotine and caffeine dependence and history of recreational use of marijuana are not exclusionary At screening, has a decrease of > = 20 mmHg systolic blood pressure or a decrease of > =10 mmHg decrease in diastolic blood pressure 2 minutes after standing, or experience symptoms of lightheadedness, dizziness, or fainting upon standing orthostatic hypotension Tests positive for the urine drug screen at screening Had an acute exacerbation of psychotic symptoms within the last 3 months before screen Relevant history or current presence of any cardiovascular, respiratory, central nervous system, neuropsychiatric (including seizures), renal, hepatic, endocrine, or immunologic diseases Has a DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder Suicidal or homicidal ideation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=575&filename=CR004270_CSR.pdf

Description

As study of the pharmacokinetics of paliperidone extended-release and risperidone immediate-release formulations

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As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations

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