NCT00838669

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_1 schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

May 18, 2011

Status Verified

March 1, 2010

First QC Date

February 5, 2009

Last Update Submit

May 17, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaMood disordersAntipsychotic drugsExtended release OROS paliperidone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • to evaluate the safety and tolerability of the treatments in healthy men

Interventions

Extended release OROS paliperidoneDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaMood Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental 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

February 5, 2009

First Posted

February 6, 2009

Study Start

August 1, 2005

Study Completion

December 1, 2005

Last Updated

May 18, 2011

Record last verified: 2010-03