NCT00758030

Brief Summary

The purpose of the study was to evaluate and compare the pharmacokinetics of ER OROS paliperidone in healthy Japanese and Caucasian patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
Last Updated

June 8, 2011

Status Verified

March 1, 2010

First QC Date

September 19, 2008

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidone

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of extended-release (ER) OROS paliperidone in healthy Japanese and Caucasian adults. Paliperidone plasma concentrations, time profiles and PK parameters after single and multiple dosing for Japanese and Caucasian patients.

Secondary Outcomes (1)

  • Pharmacogenomics: Relationships between composite genetic description or predicted observable traits and the pharmacokinetic parameters of paliperidone and its enantiomers were explored graphically.

Interventions

Paliperidone ER OROSDRUG

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese and Caucasian patients. Japanese patients had to be born in Japan of Japanese parents and not to have lived outside of Japan for more than 5 years
  • Normotensive (5 minute lying down systolic blood pressure of 100-139 mmHg and diastolic blood pressure of 60-89 mmHg)
  • Body Mass Index of 18 to 25 kg/m2
  • Considered healthy based on medical history, prestudy physical examination findings, electrocardiogram, and clinical laboratory evaluation of chemistry, hematology, and urinalysis values.

You may not qualify if:

  • History of any significant cardiovascular, respiratory, neurologic, renal, hepatic, endocrine, psychiatric, or immunologic disorders
  • Use of concomitant medication, except for paracetamol and hormonal contraceptives
  • Has received an experimental drug and/or used an experimental medical device in the 60 days before the first dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Schizophrenia

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
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 23, 2008

Study Start

March 1, 2004

Study Completion

July 1, 2004

Last Updated

June 8, 2011

Record last verified: 2010-03