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A Study of Dopamine Type 2 (D2) Receptor Occupancy Following a Single Oral Dose of OROS Paliperidone

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
OROS paliperidone
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, mood disorders, antipsychotic drugs, dopamine, receptor occupancy, OROS paliperidone

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Within 20% of ideal body weight
  • If a woman, must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study
  • and must have a negative serum beta HCG test at screening
  • Healthy on the basis of a pre-study physical examination, medical history, anamnesis, electrocardiogram, magnetic resonance imaging of the brain, and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 2 weeks before the first dose. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only on condition that the investigator judges that the deviations are not clinically significant.

Exclusion Criteria:

  • History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse
  • History of cardiac arrhythmias, bronchospastic or respiratory disease, cardiovascular, neurologic, renal, hepatic, endocrine, or immunologic disease
  • Drug allergy to raclopride, paliperidone, or risperidone or any of its excipients
  • Use of concomitant medication, except for paracetamol and hormonal contraceptives. All other medication must have been stopped at least 14 days before the first PET examination
  • Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
  • Previously used an antipsychotic medication
  • Previously participated in a PET study or measurement
  • Had a significant loss of blood <1 month before the first PET examination
  • Pregnant as confirmed by a positive beta-HCG test at screening and before the first PET examination, or breastfeeding
  • Claustrophobia.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    to evaluate D2 receptor occupancy and plasma concentration of paliperidone at defined times after intake of a single dose of OROS paliperidone 6 mg

    Secondary Outcome Measures

    to derive pharmacokinetic/pharmacodynamic relationships and the occurrence of adverse events

    Full Information

    First Posted
    November 20, 2008
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00796432
    Brief Title
    A Study of Dopamine Type 2 (D2) Receptor Occupancy Following a Single Oral Dose of OROS Paliperidone
    Official Title
    Open-label Positron Emission Tomography (PET) Study of Central D2-receptor Occupancy in Healthy Subjects Following a Single Oral Dose of OROS Paliperidone
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    The purposes of this study are to estimate the relationship of D2-receptor occupancy to plasma concentration and to assess the safety of OROS paliperidone.
    Detailed Description
    This is a single-center, single-dose, open-label, Phase-1 Positron Emission Tomography (PET) study in 4 healthy volunteers, 2 men and 2 women. After screening, healthy eligible volunteers will be hospitalized in the study unit from study Day 2 to Day 4. On Day 1 (the day before hospitalization), volunteers will enter the study unit from 5:00 p.m. to 8:00 p.m. for baseline prolactin blood sampling and sedation assessment. Each volunteer will have a control magnetic resonance imaging (at screening) and 3 PET measurements using the radioligand [11]C raclopride to measure central D2 receptor occupancy in the putamen. Blood samples to measure plasma concentrations of paliperidone will be collect immediately before and at scheduled time points after dose administration on Day 2, and immediately before, halfway through, and immediately after the PET-2 and PET-3 measurements. Serum prolactin levels will be measured immediately before and at several scheduled time points after dose administration, and immediately before and after each PET measurement. At scheduled time points, supine and standing blood pressures, pulse, sensorium changes, temperature, and degree of sedation will be recorded, volunteers will be questioned about adverse events, and they will be evaluated for extrapyramidal symptoms (EPS). Adverse events will be recorded and followed throughout the study. The rationale for the study design is based on previous PET studies with risperidone, which indicated that PET measurement of D2 receptor occupancy after a single dose of medication is useful in predicting an effective clinical dose range. Single oral dose (6 mg) of OROS paliperidone

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, mood disorders, antipsychotic drugs, dopamine, receptor occupancy, OROS paliperidone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    4 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    OROS paliperidone
    Primary Outcome Measure Information:
    Title
    to evaluate D2 receptor occupancy and plasma concentration of paliperidone at defined times after intake of a single dose of OROS paliperidone 6 mg
    Secondary Outcome Measure Information:
    Title
    to derive pharmacokinetic/pharmacodynamic relationships and the occurrence of adverse events

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Within 20% of ideal body weight If a woman, must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study and must have a negative serum beta HCG test at screening Healthy on the basis of a pre-study physical examination, medical history, anamnesis, electrocardiogram, magnetic resonance imaging of the brain, and the results of blood biochemistry and hematology tests and a urinalysis carried out less than 2 weeks before the first dose. If the results of the biochemistry or hematology tests or the urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only on condition that the investigator judges that the deviations are not clinically significant. Exclusion Criteria: History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse History of cardiac arrhythmias, bronchospastic or respiratory disease, cardiovascular, neurologic, renal, hepatic, endocrine, or immunologic disease Drug allergy to raclopride, paliperidone, or risperidone or any of its excipients Use of concomitant medication, except for paracetamol and hormonal contraceptives. All other medication must have been stopped at least 14 days before the first PET examination Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment Previously used an antipsychotic medication Previously participated in a PET study or measurement Had a significant loss of blood <1 month before the first PET examination Pregnant as confirmed by a positive beta-HCG test at screening and before the first PET examination, or breastfeeding Claustrophobia.
    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=574&filename=CR004267_CSR.pdf
    Description
    A study of dopamine type 2 (D2) receptor occupancy following a single oral dose of OROS paliperidone

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