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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

ER OROS Paliperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Mood disorders, Antipsychotic drugs, ER OROS Paliperidone

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00796835

First Posted

November 20, 2008

Last Updated

May 20, 2011

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00796835

Brief Title

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

Official Title

Dose-proportionality Study of the Five ER OROS Paliperidone To-be-marketed Tablet Strengths (3, 6, 9, 12, and 15 mg) in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

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.

Detailed Description

This study is designed as a single-center, open-label, randomized, 5 treatment-period, crossover study in healthy male adults. The study consists of a screening phase and an open-label treatment phase during which each volunteer will receive 5 treatments of study drug in a random order and separated by a washout period of 10 to 14 days. Treatments will consist of a single oral dose of: A) 1 tablet containing 3 mg ER OROS paliperidone; B) 1 tablet containing 6 mg ER OROS paliperidone; C) 1 tablet containing 9 mg ER OROS paliperidone; D) 1 tablet containing 12 mg ER OROS paliperidone; E) 1 tablet containing 15 mg ER OROS paliperidone. All treatments will be administered after an overnight fast. Volunteers are to remain in bed for 4 hours after dosing and are strongly advised to remain in bed for up to 36 hours. Five different ER OROS paliperidone tablet strengths (3, 6, 9, 12, and 15 mg) will be developed with the intent to market. Since ER OROS paliperidone is an extended release formulation, this study is designed to show dose-proportional pharmacokinetics of all these dose strengths. Safety and tolerability will be monitored throughout the study. Treatments will consist of a single oral dose of: A) 1 tablet containing 3 mg ER OROS paliperidone; B) 1 tablet containing 6 mg ER OROS paliperidone; C) 1 tablet containing 9 mg ER OROS paliperidone; D) 1 tablet containing 12 mg ER OROS paliperidone; E) 1 tablet containing 15 mg ER 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, ER OROS Paliperidone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ER OROS Paliperidone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

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=1083&filename=CR004210_CSR.pdf

Description

A dose-proportionality study of five tablet strengths of ER OROS paliperidone

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

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