NCT02049697

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Male
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	14C-JNJ-39823277	Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2014-01-30
• Last updated: 2014-01-30

Locations

1 site across 1 country: Belgium