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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177278
• Other study ID #: ACHN-490-010
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2017
• Last updated: July 11, 2017
• Start date: June 16, 2017
• Est. completion date: July 10, 2017

Study information

• Verified date: July 2017
• Source: Achaogen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-plazomicin
single intravenous dose

Locations

Country	Name	City	State
United States	Clinical Site	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Achaogen, Inc.	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total radioactivity concentration equivalents in plasma and blood		15 days
Primary	Plazomicin concentrations in plasma and urine		15 days
Secondary	Incidence and severity of adverse events		21 days
Secondary	Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)		1 day
Secondary	Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)		4 days
Secondary	Physical examination		Screening