A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 19 - 55 |
| Updated: | 7/13/2017 |
| Start Date: | June 16, 2017 |
| End Date: | July 10, 2017 |
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
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.
study of a single IV infusion of [14C]-plazomicin in healthy, adult male subjects.
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
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