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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Jun 2017
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedStudy Start
First participant enrolled
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2017
CompletedJuly 12, 2017
July 1, 2017
24 days
June 1, 2017
July 11, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Incidence and severity of adverse events
21 days
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
Physical examination
Screening
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Achaogen, Inc.lead
- Celerioncollaborator
Study Sites (1)
Clinical Site
Lincoln, Nebraska, 68502, United States
Study Officials
- STUDY DIRECTOR
Shyeilla Dhuria
Achaogen, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2017
First Posted
June 6, 2017
Study Start
June 16, 2017
Primary Completion
July 10, 2017
Study Completion
July 10, 2017
Last Updated
July 12, 2017
Record last verified: 2017-07