drugset / Trial / NCT03947814

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

NCT03947814

Phase 1 Terminated 29 enrolled Janssen-Cilag International NV
Non-randomizedParallel-groupOpen-labelOther

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).

Timeline

Start
2019-07-02
Primary completion
2020-09-09
Completion
2020-09-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimodivir Small molecule 600 mg Oral