NCT03947814

A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment

A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of pimodivir after a single oral dose of 600 milligrams (mg) in adult participants with severe renal impairment who are not on dialysis and in adult participants with end-stage renal disease (ESRD) who are not yet on dialysis compared to adult participants with normal renal function (Part A). Optionally, to evaluate the PK in adult participants with mild and/or moderate renal impairment compared to adult participants with normal renal function (Part B).

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Pimodivir	Participants will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Timeline

• Start date: 2019-07-02
• Primary completion: 2020-09-09
• Completion: 2020-09-09
• First posted: 2019-05-13
• Last updated: 2025-02-03

Locations

2 sites across 1 country: Germany