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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-16

Study Completion Date

2017-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers

NCT04092712

Healthy Volunteers

COMPLETED PHASE1

A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

NCT02994381

Healthy Volunteers

COMPLETED PHASE1

Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

NCT03301298

Healthy

COMPLETED PHASE1

A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body

NCT03495934

Healthy Subjects

COMPLETED PHASE1

Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

NCT03886103

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

[14C]-plazomicin

Intervention Type DRUG

single intravenous dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[14C]-plazomicin

single intravenous dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings

Exclusion Criteria

* Use of tobacco- or nicotine-containing products
* Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe
* History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
* History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
* History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes