NCT00796029

Brief Summary

The purposes of this study are to investigate the metabolic pathways of paliperidone and excretion of paliperidone and its metabolites in healthy adult male volunteers, both CYP2D6 poor and extensive metabolizers, after administration of a single 1-mg oral dose of 14C-paliperidone, to evaluate the safety and tolerability of paliperidone, and to determine the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure to paliperidone and its metabolites.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Jul 2003

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

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
5.4 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 drugs: 14C-paliperidone

Outcome Measures

Primary Outcomes (1)

  • To investigate the metabolic pathways of paliperidone and excretion of paliperidone and its metabolites in healthy adult male volunteers,both poor and extensive metabolizers for CYP2D6,after administration of a single 1 mg oral dose of 14C paliperidone

Secondary Outcomes (1)

  • To evaluate the safety and tolerability of paliperidone, as well as the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure to paliperidone and its metabolites

Interventions

14C-paliperidoneDRUG

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Dextromethorphan metabolic ratio of \>0.345 (poor metabolizer) or \<0.0255 (extensive metabolizer)
  • Body Mass Index: (weight \[kg\]/height \[m\]2) between 20 and 28 kg/m2, inclusive
  • Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Healthy based on a prestudy physical examination, medical history, ECG, the results of hematology and serum chemistry tests, and a urinalysis carried out within the 3 weeks prior to administration of study drug. If the results of the hematology tests, serum chemistry tests (except for liver enzymes and serum creatinine), or the urinalysis are not within the laboratory's reference ranges, the volunteer can be included only on the condition that the investigator judges that the deviations are not clinically significant.

You may not qualify if:

  • Relevant history of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g., history of ischemic heart disease or cerebrovascular accident)
  • respiratory, neuropsychiatric, renal, hepatic, gastrointestinal (including surgeries, and malabsorption problems), endocrine (including diabetes mellitus and thyrotoxicosis), or immunologic diseases
  • parkinsonism
  • or drug allergy
  • History of any cancer, with the exception of basal cell carcinoma
  • Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
  • 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
  • History of alcohol or substance abuse. Positive test results for urine drug screen or alcohol breath test upon admission to the study center on Day 1
  • Positive results for any of the serology tests (hepatitis B surface antigen, human immunodeficiency virus \[HIV\] antibody, and hepatitis C viral antibody)
  • Liver function tests or serum creatinine exceeding normal limits at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Vermeir M, Naessens I, Remmerie B, Mannens G, Hendrickx J, Sterkens P, Talluri K, Boom S, Eerdekens M, van Osselaer N, Cleton A. Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist, in humans. Drug Metab Dispos. 2008 Apr;36(4):769-79. doi: 10.1124/dmd.107.018275. Epub 2008 Jan 28.

    PMID: 18227146RESULT

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 24, 2008

Study Start

July 1, 2003

Study Completion

July 1, 2003

Last Updated

June 8, 2011

Record last verified: 2010-03