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SchizophreniaPhase 1NCT00796185

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

A Phase 1 study testing Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Schizophrenia, Schizoaffective Disorder
What is being tested?
Paliperidone ER
How many people
62 participants
Where
No sites listed yet
Study dates
Aug 2003to Jan 2004
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

About this study

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

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.

Read the 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

Being tested
Paliperidone ER
Keywords
Schizophrenia, Schizoaffective Disorder, Mood Disorders, Antipsychotic drugs, Paliperidone ER
Medical subject headings
Schizophrenia, Psychotic Disorders, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paliperidone ERDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (1)

  1. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2008 (estimated)
  2. Study startAug 2003
  3. Study completionJan 2004

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796185
Sponsor's protocol ID
CR004270
Status last verified
Mar 2010
First submitted
20 Nov 2008
Last updated
8 Jun 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, 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 7 inclusion and 9 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 8 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 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796185.

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 8 Jun 2011.

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