A Dose-proportionality Study of Five Tablet Strengths of ER OROS Paliperidone

NCT00796835 | Completed Phase 1

• 1 other identifier: CR004210
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the dose proportionality of the 3-, 6-, 9-, 12-, and 15-mg tablets of ER OROS paliperidone. Additionally, the safety and tolerability of the treatments in healthy volunteers will be assessed.

Conditions

Schizophrenia

Keywords

Schizophrenia; Mood disorders; Antipsychotic drugs; ER OROS Paliperidone

Outcome Measures

Primary Outcomes (1)

• To evaluate the dose proportionality of the 3-, 6-, 9-, 12-, and 15-mg tablets of ER OROS paliperidone

Secondary Outcomes (1)

• To evaluate the safety and tolerability of the treatments in healthy volunteers

Interventions

ER OROS Paliperidone DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (weight \[kg\]/height \[m²\]) of 18 to 28 kg/m², inclusive
• Normotensive with supine (5 minutes) blood pressure between the range of 100 to 140 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive
• Healthy on the basis of a prestudy physical examination, medical history, ECG, and the laboratory results of serum chemistry, hematology and urinalysis performed within 21 days before the first dose. If the results of the serum chemistry, hematology or urinalysis testing are not within the laboratory's reference ranges the volunteer can be included only if the investigator judges that the deviations are not clinically significant
• For renal function tests, the values must be within the normal laboratory reference range.

You may not qualify if:

• Recent history of alcohol or substance abuse, a positive test result for the urine drug screen at screening or upon admittance to the testing facility or a positive result for the alcohol breath test upon admittance to the testing facility
• Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic or immunologic disease
• History of any cancer, with the exception of basal cell carcinoma
• At screening, has a sustained decrease of \>20 mmHg in systolic blood pressure or a decrease of \>10 mmHg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of \>15 beats per minute (bpm) in heart rate
• Bradycardia (heart rate \<50 bpm) as determined by screening ECG
• History of a positive result for any of the serology tests (hepatitis B, C, and HIV)
• History of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. Volunteers must agree to refrain from use throughout the study

Sponsors & Collaborators

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

Related Links

• A dose-proportionality study of five tablet strengths of ER 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: July 1, 2004
• Study Completion: October 1, 2004
• Last Updated: May 24, 2011

Record last verified: 2010-03