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

NCT00796432 | Completed Phase 1

• 1 other identifier: CR004267
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; mood disorders; antipsychotic drugs; dopamine; receptor occupancy; OROS paliperidone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

OROS paliperidone DRUG

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study of dopamine type 2 (D2) receptor occupancy following a single oral dose of OROS paliperidone

MeSH Terms

Conditions

Schizophrenia; Mood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: March 1, 2003
• Study Completion: June 1, 2003
• Last Updated: June 10, 2011

Record last verified: 2010-03