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A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin

NCT03177278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-07-12

No results posted yet for this study

Summary

This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of \[14C\]-plazomicin in healthy, adult male subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C]-plazomicin

single intravenous dose

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Achaogen, Inc.

    lead INDUSTRY

Principal Investigators

  • Shyeilla Dhuria · Achaogen, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2017-07-10
Completion
2017-07-10
FDA Drug
Yes

Countries

  • United States

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 NCT03177278 on ClinicalTrials.gov