A Study of the Dose Proportionality of Extended Release Paliperidone - Full Text View

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00791167

Purpose

The purposes of this study are to evaluate the dose proportionality of 1.5- and 3 mg tablets of paliperidone ER, to document the pharmacokinetics of a 1.5 mg dose of paliperidone ER, and to assess the safety and tolerability of the 1.5- and 3 mg tablets in healthy men.

Condition	Intervention	Phase
Schizophrenia	Drug: Paliperidone ER	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	Evaluation of the Dose Proportionality of Two Dose Strengths (1.5 and 3 mg) of Extended-Release Paliperidone After a Single Administration to Healthy Men

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Paliperidone

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

To evaluate dose-proportionality of 1.5 and 3-mg tablets of paliperidone ER

Secondary Outcome Measures:

To document the pharmacokinetics of a 1.5-mg dose of paliperidone ER in healthy men and to assess the safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men

Enrollment:	58
Study Start Date:	June 2006
Study Completion Date:	August 2006

Detailed Description:

This is a randomized, open label, single center, single dose, 2 treatment, 2 way crossover study. It consists of 3 phases: A screening phase beginning within 21 days before the first study drug administration; an open label treatment phase consisting of 2 treatment periods (Period 1 and Period 2) during which volunteers will receive a single oral 1.5 or 3 mg dose of study drug; and end of study evaluations upon completion of all the study procedures in Period 2. All volunteers will receive each of the following 2 treatments in random order: Treatment A: One tablet of 1.5 mg paliperidone ER to-be-marketed formulation in the fasted state; Treatment B: One tablet of 3 mg paliperidone ER Phase 3 formulation in the fasted state. Successive study drug administrations will be separated by a washout period of at least 9 days and no more than 21 days. A 1.5-mg dose of paliperidone ER was selected to be studied as the availability of a 1.5-mg tablet would make dose-adjustments across the existing range of doses of paliperidone ER easier in patients with reduced renal function or tolerability issues. Safety and tolerability of the 1.5- and 3 mg tablets of paliperidone ER in healthy men will be monitored throughout the study.

A single oral doses of 1.5 mg and 3 mg paliperidone ER

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Body mass index ( weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
Have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
Healthy on the basis of a prestudy physical examination, medical history, 12-lead 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 ranges

Exclusion Criteria:

Known drug allergy to risperidone, paliperidone, or any of its excipients
Known history of drug-induced dystonia
Recent history of alcohol or substance abuse
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 signs of autonomic dysfunction as indicated by 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 12-lead ECG
A positive test result (or history of) for any of the serology tests (hepatitis B and C, and human immunodeficiency virus) at screening
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
Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of study drug. Exception for acetaminophen (paracetamol) or ibuprofen, which is allowed up to 3 days before first dose of study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791167

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

Additional Information:

A study of the dose proportionality of extended release paliperidone This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR011437
Study First Received:	November 13, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00791167 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Mood Disorders, Antipsychotic drugs
Schizophrenia
Paliperidone ER

Study placed in the following topic categories:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs
Risperidone
Mood Disorders

Central Nervous System Depressants
9-hydroxy-risperidone
Psychotic Disorders
Healthy
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009