NCT03189498

A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function

A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Subjects With Various Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease \[ESRD\] with or without hemodialysis) compared to adult participants with normal renal function.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	JNJ-64041575	All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2017-06-16
• Last updated: 2025-02-03

Locations

2 sites across 1 country: Germany