CompletedPhase 1

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

United States20 participantsStarted 2018-03-23

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety assessed by number of abnormal clinical laboratory test result

Timeframe: every 8 hours

To measure the Maximum Concentration

Timeframe: 24 hrs

To measure the Area Under the Curve [AUC]

Timeframe: 24 hrs

Safety assessed by number of abnormal physical examinations findings.

Timeframe: every 8 hours

Safety assessed by number of abnormal vital signs findings

Timeframe: every 8 hours

Safety assessed by number of abnormal 12 Lead ECG findings

Timeframe: every 8 hours

Trial details

NCT IDNCT03622008

SponsorWockhardt

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-13

View on ClinicalTrials.gov More Antibiotics Causing Adverse Effects in Therapeutic Use trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety assessed by number of abnormal clinical laboratory test result

Timeframe: every 8 hours

To measure the Maximum Concentration

Timeframe: 24 hrs

To measure the Area Under the Curve [AUC]

Timeframe: 24 hrs

Safety assessed by number of abnormal physical examinations findings.

Timeframe: every 8 hours

Safety assessed by number of abnormal vital signs findings

Timeframe: every 8 hours

Safety assessed by number of abnormal 12 Lead ECG findings

Timeframe: every 8 hours