A Study of the Effect of Food and Posture on the Pharmacokinetics of a Single Dose of ER OROS Paliperidone

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00838669
First received: February 5, 2009
Last updated: May 17, 2011
Last verified: March 2010
  Purpose

The purposes of this study are to evaluate the effect of food on the pharmacokinetics of extended-release (ER) OROS paliperidone in healthy men, and to evaluate the effect of posture on the pharmacokinetics of ER OROS paliperidone under fasting conditions. Additionally, the safety and tolerability of the treatments in healthy men will be assessed.


Condition Intervention Phase
Schizophrenia
Drug: Extended release OROS paliperidone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Food and Posture on the Pharmacokinetics of Paliperidone After a Single Administration of 12 mg ER OROS Paliperidone to Healthy Men

Resource links provided by NLM:


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

Primary Outcome Measures:
  • to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in ambulant healthy men; to evaluate the effect of posture on the pharmacokinetics of ER OROS paliperidone under fasting conditions

Secondary Outcome Measures:
  • to evaluate the safety and tolerability of the treatments in healthy men

Enrollment: 74
Study Start Date: August 2005
Study Completion Date: December 2005
Detailed Description:

The current study was designed to evaluate the effect of food on the pharmacokinetics of the to be marketed formulation of ER OROS paliperidone in mobile healthy men, which represents the normal conditions. The 12-mg ER OROS paliperidone ER by oral administration single dose used in this study does not require prolonged bed rest as a precautionary measure to prevent orthostatic hypotension. To support an evaluation of the effect of posture on the pharmacokinetics of ER OROS paliperidone under fasting conditions, study medication was also administered to healthy men in the fasted state while confined to bed for approximately 36 hours. The safety and tolerability of the treatments in healthy men will be assessed. 12 mg ER OROS paliperidone ER, oral administration, single dose

  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
  • 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 male 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
  • Known allergy or history of significant hypersensitivity to heparin, if a heparin lock will be used
  • 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, a positive result for the alcohol urine 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 carcinomas
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838669

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00838669     History of Changes
Other Study ID Numbers: CR006223
Study First Received: February 5, 2009
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Schizophrenia
Mood disorders
Antipsychotic drugs
Extended release OROS paliperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
9-hydroxy-risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014