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

NCT03622008 | Completed Phase 1 FDA Drug

• 1 other identifier: W-4282-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (6)

• Safety assessed by number of abnormal clinical laboratory test result

  every 8 hours

• To measure the Maximum Concentration

  24 hrs

• To measure the Area Under the Curve [AUC]

  24 hrs

• Safety assessed by number of abnormal physical examinations findings.

  every 8 hours

• Safety assessed by number of abnormal vital signs findings

  every 8 hours

• Safety assessed by number of abnormal 12 Lead ECG findings

  every 8 hours

Study Arms (2)

FEP-TAZ 4 g

EXPERIMENTAL

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

Drug: FEP-TAZ 4 g

Placebo

PLACEBO COMPARATOR

placebo IV

Other: Placebo

Interventions

FEP-TAZ 4 g DRUG

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

FEP-TAZ 4 g

Placebo OTHER

Placebo IV

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wockhardt: lead
• Clinartis, LLC: collaborator

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind study
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive one of the following IV treatments as a q8h infusion (90 min) regimen for 10 days: * FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) (n=16) * Placebo (n=4)

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: August 9, 2018
• Study Start: March 23, 2018
• Primary Completion: May 13, 2018
• Study Completion: May 30, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

US (1)