NCT03630094

Brief Summary

This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

March 17, 2017

Last Update Submit

August 13, 2018

Conditions

PHA1A

Outcome Measures

Primary Outcomes (2)

  • concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)

    Day 3

  • concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)

    Day 3

Secondary Outcomes (2)

  • Number of adverse event reported

    Day 3

  • number variation noted in 12-lead electrocardiogram

    Day 3

Study Arms (1)

FEP-ZID via intravenous

EXPERIMENTAL

total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen

Drug: FEP-ZID

Interventions

FEP-ZIDDRUG

A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen

FEP-ZID via intravenous

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
  • Medical history without any major pathology as judged by the Investigator.
  • Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.

You may not qualify if:

  • History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • Positive alcohol breath test or urine drug screen test at screening or confinement.
  • Current use or has used tobacco or nicotine containing products 6 month prior to screening.
  • Positive testing for HIV, Hepatitis B or Hepatitis C.
  • History or presence of alcohol or drug abuse within the 2 years prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2017

First Posted

August 14, 2018

Study Start

March 31, 2017

Primary Completion

June 30, 2017

Study Completion

July 30, 2017

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)