NCT00796471

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of 2 extended-release (ER) formulations of 2 mg-eq paliperidone in comparison to the 2 mg immediate-release (IR) paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations. Additional objectives are to compare the pharmacodynamic effects (postural changes in blood pressure and heart rate), safety, and tolerability are to be evaluated in addition to exploring the relationship between CYP2D6 and CYP3A4/5genotype and paliperidone exposure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Jun 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
Last Updated

June 8, 2011

Status Verified

March 1, 2010

First QC Date

November 20, 2008

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaMood DisordersAntipsychotic drugsPaliperidone ER

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pharmacokinetics of 2 ER formulations of 2 mg-eq paliperidone in comparison with 2 mg IR paliperidone oral solution and to evaluate the effect of food on the pharmacokinetics of these ER formulations

Secondary Outcomes (1)

  • To compare the pharmacodynamic effects (postural changes in blood pressure and heart rate) of all treatments

Interventions

Paliperidone ERDRUG

Eligibility Criteria

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

You may qualify if:

  • Acceptable weight as defined by body mass index (weight \[kg\]/height (m)²) range of 18.0 to 28.0 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, electrocardiogram, and the laboratory results of blood biochemistry, hematology and urinalysis performed within 21 days before the first dose. If the results of the biochemistry, 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 liver function tests (alanine transaminase, aspartate transaminase, and bilirubin), the values must be contained within 2 times the upper limits of the normal laboratory reference ranges and for renal function tests, the values must be within the normal laboratory reference ranges
  • Women must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization and at the discretion of the investigator, total abstinence) before entry and throughout the study, as well as have a negative serum pregnancy test at screening. To ensure continued eligibility, women must have a negative urine test before each dose of study drug (Day -1 for each period).

You may not qualify if:

  • Known allergy or history of significant hypersensitivity to heparin
  • Recent history of alcohol or substance abuse. Test positive for the urine drug screen at screening or the urine drug screen or alcohol breath test at Day -1 for Period 1
  • Relevant history of any cardiovascular, respiratory neuropsychiatric, renal, hepatic, gastrointestinal (including surgeries, and malabsorption problems), endocrine, or immunologic diseases
  • A decrease of greater than or equal to 20 mmHg systolic blood pressure 3 minutes after standing, or with symptoms of lightheadedness, dizziness or fainting upon standing at screening
  • 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.)
  • Drug allergy to risperidone, paliperidone, or any of its excipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaMood Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

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

November 20, 2008

First Posted

November 24, 2008

Study Start

June 1, 2003

Study Completion

August 1, 2003

Last Updated

June 8, 2011

Record last verified: 2010-03