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A Study to Evaluate of the Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 in Healthy Male Participants

Healthy Clinical Trial

Official title:
Absorption, Metabolism, and Excretion of 14C-JNJ-39823277 (TPI 1062) After a Single Oral Dose in Healthy Male Subjects

Clinical Trial Summary

The purpose of this study is to investigate the absorption, metabolic pathways and excretion of JNJ-39823277 in healthy male adults after administration of a single oral dose of a 25 mg (0.5 mg/mL solution) of 14C-JNJ-39823277.

Clinical Trial Description

This is an open-label (all people know the identity of the intervention) and single-arm (group) study. The study consists of 3 phases including, the screening phase (within 3 weeks prior to the start of study medication), treatment phase (8 to 15 days), and the follow-up phase (up to 6 days after the discharge from the hospital). Approximately 6 participants will be receiving the 14C-JNJ-39823277 in the study. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study will be up to approximately 6 weeks. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02049697
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Completed
Phase Phase 1
Start date April 2009
Completion date May 2009
View Details
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