Antibiotics Causing Adverse Effects in Therapeutic UsePhase 1NCT03622008
To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)
A Phase 1 study testing FEP-TAZ 4 g in people with Antibiotics Causing Adverse Effects in Therapeutic Use, run by Wockhardt at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- FEP-TAZ 4 g
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 30 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
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
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.
- Being tested
- FEP-TAZ 4 g, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEP-TAZ 4 gDrug
FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days
PlaceboOther
Placebo IV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: FEP-TAZ 4 g |
| Placebo | Placebo comparator | placebo IV Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by number of abnormal clinical laboratory test result
Measured: every 8 hours
To measure the Maximum Concentration
Measured: 24 hrs
To measure the Area Under the Curve [AUC]
Measured: 24 hrs
Safety assessed by number of abnormal physical examinations findings.
Measured: every 8 hours
Safety assessed by number of abnormal vital signs findings
Measured: every 8 hours
Safety assessed by number of abnormal 12 Lead ECG findings
Measured: every 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start23 Mar 2018
- Primary completion13 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotics Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinartis, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622008
- Sponsor's protocol ID
- W-4282-105
- Status last verified
- Aug 2018
- First submitted
- 15 Jul 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03622008
- Acronym / sponsor ID
- W-4282-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- WockhardtIndustry (pharma, biotech, devices)
- Collaborators
- Clinartis, LLC
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 13 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| FEP-TAZ 4 g | Experimental | Drug: FEP-TAZ 4 gFEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days |
| Placebo | Placebo comparator | Other: Placeboplacebo IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEP-TAZ 4 gFEP-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 |
| PlaceboPlacebo IV | Other | Placebo |
Primary outcome
Safety assessed by number of abnormal clinical laboratory test result
Time frame: every 8 hours
To measure the Maximum Concentration
Time frame: 24 hrs
To measure the Area Under the Curve [AUC]
Time frame: 24 hrs
Safety assessed by number of abnormal physical examinations findings.
Time frame: every 8 hours
Safety assessed by number of abnormal vital signs findings
Time frame: every 8 hours
Safety assessed by number of abnormal 12 Lead ECG findings
Time frame: every 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FEP-TAZ 4 g in people with Antibiotics Causing Adverse Effects in Therapeutic Use, run by Wockhardt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by number of abnormal clinical laboratory test result (time frame: every 8 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.