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

Sponsor

Achaogen, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03177278

Collaborator

Celerion (Industry)

Enrollment

Location

Arm

Actual Duration (Days)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C]-plazomicin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 16, 2017

Actual Primary Completion Date :

Jul 10, 2017

Actual Study Completion Date :

Jul 10, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: [14C]-plazomicin

single intravenous dose

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

Achaogen, Inc.
Celerion

Investigators

Study Director: Shyeilla Dhuria, Achaogen, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Achaogen, Inc.

ClinicalTrials.gov Identifier:

NCT03177278

Other Study ID Numbers:

ACHN-490-010

First Posted:

Jun 6, 2017

Last Update Posted:

Jul 12, 2017

Last Verified:

Jul 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 12, 2017