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

NCT03947814 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-02-03

No results posted yet for this study

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

DRUG

Pimodivir

Participants will receive single oral dose of 600 mg pimodivir as 2\*300 mg tablets.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947814 on ClinicalTrials.gov