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

Achaogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C]-plazomicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03177278

ACHN-490-010

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: [14C]-plazomicin