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
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
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
NCT ID
NCT00796432
First Posted
November 20, 2008
Last Updated
June 8, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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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A Study of Dopamine Type 2 (D2) Receptor Occupancy Following a Single Oral Dose of OROS Paliperidone
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