NCT03002779

A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Healthy Male Participants

A Phase 1, Open Label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-53718678 After a Single Dose in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-53718678	Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.

Timeline

• Start date: 2017-01-26
• Primary completion: 2017-03-10
• Completion: 2017-03-20
• First posted: 2016-12-26
• Last updated: 2017-05-31

Locations

1 site across 1 country: Netherlands