Status:
COMPLETED
A Study of Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral Dose
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
MALE
40-60 years
Phase:
PHASE1
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 ...
Detailed Description
This study is designed as a single-center, single-dose, open-label study of the absorption, metabolism, and excretion of paliperidone in healthy men (3 extensive and 3 poor metabolizers based on CYP2D...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00796029
Start Date
July 1 2003
End Date
July 1 2003
Last Update
June 8 2011
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