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

Achaogen, Inc.1 site in 1 country6 target enrollmentJune 16, 2017

ConditionsHealthy Volunteers

Interventions[14C]-plazomicin

Drugs[14C]-plazomicin

Overview

Phase: Phase 1
Intervention: [14C]-plazomicin
Conditions: Healthy Volunteers
Sponsor: Achaogen, Inc.
Enrollment: 6
Locations: 1
Primary Endpoint: Total radioactivity concentration equivalents in plasma and blood
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 16, 2017

End Date

July 10, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Achaogen, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings

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

Arms & Interventions

Arm 1

Intervention: [14C]-plazomicin

Outcomes

Primary Outcomes

Total radioactivity concentration equivalents in plasma and blood

Time Frame: 15 days

Plazomicin concentrations in plasma and urine

Time Frame: 15 days

Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis

Time Frame: 15 days

Secondary Outcomes

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)