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

A Phase 1, Open-Label Study to Assess the Metabolism, Excretion, and Mass Balance of [14C]-Plazomicin Following a Single IV Infusion in Healthy Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03177278

Enrollment

Registered

2017-06-06

Start date

2017-06-16

Completion date

2017-07-10

Last updated

2017-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief 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.

Interventions

DRUG[14C]-plazomicin

single intravenous dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis	15 days
Total radioactivity concentration equivalents in plasma and blood	15 days
Plazomicin concentrations in plasma and urine	15 days

Secondary

Measure	Time frame
Incidence and severity of adverse events	21 days
Physical examination	Screening
Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)	1 day
Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)	4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026