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OpenTrials
Completed

NCT Number: NCT03177278

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]-plazomicin

Drug

single intravenous dose

Primary outcomes

  1. Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis

    Time frame: 15 days

  2. Total radioactivity concentration equivalents in plasma and blood

    Time frame: 15 days

  3. Plazomicin concentrations in plasma and urine

    Time frame: 15 days

Secondary outcomes

  1. Incidence and severity of adverse events

    Time frame: 21 days

  2. Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)

    Time frame: 1 day

  3. Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)

    Time frame: 4 days

  4. Physical examination

    Time frame: Screening

Sponsors and collaborators

Lead sponsor

Achaogen, Inc.

Industry

Collaborators

  • Celerion

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 6, 2017
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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