NCT02524717

A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function

A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Aragon Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.

Detailed description

This is an open-label (all people know the identity of the intervention), single-dose, single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of participation in the study for each participant is approximately 78 Days. Primarily the pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored throughout the study.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	JNJ-56021927	Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.

Timeline

• Start date: 2015-08-13
• Primary completion: 2017-02-09
• Completion: 2017-02-09
• First posted: 2015-08-17
• Last updated: 2025-02-03

Locations

2 sites across 1 country: United States