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OpenTrials
Completed

NCT Number: NCT03622008

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

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.

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Key information

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Other

Placebo IV

Primary outcomes

  1. Safety assessed by number of abnormal clinical laboratory test result

    Time frame: every 8 hours

  2. To measure the Maximum Concentration

    Time frame: 24 hrs

  3. To measure the Area Under the Curve [AUC]

    Time frame: 24 hrs

  4. Safety assessed by number of abnormal physical examinations findings.

    Time frame: every 8 hours

  5. Safety assessed by number of abnormal vital signs findings

    Time frame: every 8 hours

  6. Safety assessed by number of abnormal 12 Lead ECG findings

    Time frame: every 8 hours

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Collaborators

  • Clinartis, LLC

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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