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

NCT ID: NCT00838669

Last Updated: 2011-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2005-12-31

Brief Summary

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.

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

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Extended release OROS paliperidone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=710&filename=CR006223_CSR.pdf

A study of the effect of food and posture on the pharmacokinetics of a single dose of ER OROS paliperidone

Other Identifiers

CR006223

Identifier Type: -

Identifier Source: org_study_id