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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-plazomicin

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: [14C]-plazomicin; single intravenous dose

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Achaogen, Inc.
• Collaborators: Celerion

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ACHN-490-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No