Plasma and Intrapulmonary Concentrations Study of WCK 5222 | NCT03630094

Studies
Plasma and Intrapulmonary Concentrations Study of WCK 5222

NCT03630094

Sponsor

Wockhardt

Status

Completed

Last Update Posted

Aug 14, 2018Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

PHA1A

Interventions

FEP-ZID

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2017Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jul 30, 2017Actual

First Submitted Date

Mar 17, 2017

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2018

Last Update Posted Date

Aug 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FEP-ZID	Drug	A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen	FEP-ZID via intravenous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of adverse event reported		Day 3
number variation noted in 12-lead electrocardiogram		Day 3

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Associates		Phoenix	Arizona	85006	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided