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Plazomicin Study in ESRD Patients Receiving IHD

NCT04699656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-03-09

No results posted yet for this study

Summary

This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.

Conditions

Interventions

DRUG

Plazomicin Injection

single dose of plazomicin

Sponsors & Collaborators

  • Cipla USA Inc.

    lead INDUSTRY

Principal Investigators

  • Patrice P Rioux, MD, PhD · Cipla USA Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2021-03-08
Completion
2021-06-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04699656 on ClinicalTrials.gov