To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)

Antibiotics Causing Adverse Effects in Therapeutic Use Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind Study to Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) After Intravenous Administrations in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622008
• Other study ID #: W-4282-105
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2018
• Est. completion date: May 30, 2018

Study information

• Verified date: August 2018
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 30, 2018
• Est. primary completion date: May 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a body Mass Index (BMI) between 18 to 32 kg/m2 (both inclusive).

• Medical history without any major pathology.

• A sustained supine systolic blood pressure <150 mm Hg or >90 mm Hg or a supine diastolic blood pressure <95 mm Hg or >50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position.

• Glomerular filtration rate (GFR) > 80 mL/min, estimated by the Cockcroft-Gault equation.

Exclusion Criteria:

• Use of cefepime and/or tazobactam within 60 days prior to study drug administration.

• History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Related Conditions & MeSH terms

• Antibiotics Causing Adverse Effects in Therapeutic Use

Intervention

Drug:
• FEP-TAZ 4 g
FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days

Other:
• Placebo
Placebo IV

Locations

Country	Name	City	State
United States	Spaulding Clinical Research	West Bend	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Wockhardt	Clinartis, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by number of abnormal clinical laboratory test result		every 8 hours
Primary	To measure the Maximum Concentration		24 hrs
Primary	To measure the Area Under the Curve [AUC]		24 hrs
Primary	Safety assessed by number of abnormal physical examinations findings.		every 8 hours
Primary	Safety assessed by number of abnormal vital signs findings		every 8 hours
Primary	Safety assessed by number of abnormal 12 Lead ECG findings		every 8 hours