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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-plazomicin

• Registration Number: NCT03177278
• Lead Sponsor: Achaogen, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-02
• Study First Posted: 2017-06-06
• Study Start: 2017-06-16
• Status Verified: 2017-07
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-10
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	[14C]-plazomicin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Lincoln, Nebraska, United States