- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05645757
Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777) In Healthy Adult Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Martin Kankam
- Phone Number: 19136961601
- Email: mkankam@altasciences.com
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Altasciences Inc - Kansas City
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provide a signed and dated written informed consent and agrees to comply with the study procedures and length of confinement to the research site.
- Be able to understand and willing to comply with study procedures, restrictions, and requirements, as determined by the Site Principal Investigator (PI) or authorized clinician(s) (listed on FDA Form 1572).
- Adults 18 to 45 years of age inclusive, including non-pregnant, non-lactating females.
- Have suitable veins for cannulation or repeated venipuncture.
Be in good general health at the time of enrollment. Note 1: Determined by medical history (MH), medication use, physical examination (PE), vital signs (VS), clinical laboratory tests including estimated creatinine clearance (CLCR) > / = 80 mL/min by the Cockcroft-Gault method, and 12-lead Electrocardiogram (ECG) within reference ranges at Screening and Day-1.
Note 2: Exceptions to Blood Pressure (BP), Heart Rate (HR) and laboratory test values being with normal ranges are:
- Subjects with baseline HR > / = 45 to 50 Beats per Minute (bpm) may be accepted if otherwise healthy adults with known history of asymptomatic bradycardia.
- Subjects with baseline Systolic Blood Pressure (SBP) up to 140 Millimeters of Mercury (mmHg) and Diastolic Blood Pressure (DBP) up to 90 mmHg may be accepted if otherwise healthy.
- A laboratory value that is Grade 1 will be allowed if not considered to be clinically significant by the investigator, with the exception of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), total and direct bilirubin, Blood Urea Nitrogen (BUN), serum creatinine, Creatinine Clearance (CLcr), and urine protein.
Sexually active females must be of non-childbearing potential or must use a highly effective method of birth control from screening to 30 days following the last dose of study product.
Note 1: A female is considered of childbearing potential unless post-menopausal (defined as history of > / = 1 year of spontaneous amenorrhea and a Follicle-Stimulating Hormone (FSH) level >40 IU/L), or permanently surgically sterilized.
Note 2: Highly effective contraceptive methods include: (a) surgical sterilization methods, such as tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful tubal obliteration (e.g., Essure(R)) with documented radiological confirmation test at least 90 days after the procedure, or (b) long-acting reversible contraception, such as progestin-releasing subdermal implants, copper intrauterine devices (IUDs), levonorgestrel-releasing IUDs.
Note 3: A subject who is not sexually active and abstains from sexual intercourse can be enrolled and abstinence documented.
Sexually active males must be vasectomized or agree to use barrier contraception and not donate sperm from first dose of study product until 30 days following the last dose.
Note 1: Barrier contraception includes use of condom with spermicide. Note 2: A subject who is not sexually active and abstains from sexual intercourse can be enrolled and abstinence documented.
- Subjects must be willing to avoid excessive physical exercise within 48 h prior to dosing until discharge from the CTU on Day 8, and 24 h before the last visit (Day 11 +3 days).
- No history of acute febrile or infectious illness for at least 7 days prior to the administration of study drug(s).
Exclusion Criteria:
- Known history of a clinically significant food or drug allergy/hypersensitivity including known allergy/hypersensitivity to Ertapenem (ERT), any ß-lactam drugs or other related drugs.
- Current seasonal allergies with ongoing symptoms for more than a week prior to dosing requiring glucocorticoids and/or frequent use of antihistamines for treatment.
Any history of a chronic condition including renal failure that may increase risk to subject or interfere with endpoint assessment, or any unstable chronic disease.
Note 1: Unstable chronic disease is defined by need for frequent medical interventions that lead to a change in medications and/or required hospitalization, surgery or an invasive procedure or emergency department/urgent care visit, as determined by the Site PI.
Note 2: Any chronic disease, that has been diagnosed within 90 days of screening is excluded.
- History of any psychiatric condition that has required hospitalization in the last 12 months or subject is considered psychologically unstable by the investigator.
- History of any clinically significant (CS) disease or disorder, medical/surgical procedure, or trauma within 4 weeks prior to initiation of administration of study product(s).
- History of Clostridium difficile induced diarrhea within 1 year before screening
- Known history of past or current epilepsy or seizure disorders, excluding febrile seizures of childhood.
- Prior exposure to Zidebactam (ZID).
- Use of any prohibited prescription or non-prescription medication within 14 days prior to the first dose of study drug(s) as described in Section 6.6
- Use of any investigational drug product within 30 days or 5 half-lives (whichever is longer) before investigational product administration in this study.
- Planned participation in a clinical research study that requires treatment with a study drug, blood draws or other invasive assessments during the study period (screening until final visit).
- Blood or plasma donation of 500 mL within 3 months or more than 100 mL within 30 days before signing informed consent or planned donation prior to completion of this trial.
- Positive serum pregnancy test for women at screening and urine pregnancy test at check-in.
- Positive urine alcohol test or urine drug screen test at screening or check-in (Day -1).
- Positive test for HIV antibodies, hepatitis B-virus surface antigen (HBsAg), or anti-hepatitis C-virus antibodies (anti-HCV) at screening.
History of > / = 10 pack-years smoking in the 5-year period before screening, or positive urine cotinine screen at check-in.
Note 1: Nicotine products include cigarettes, e-cigarettes, pipe, cigar, chewing tobacco, nicotine patch.
Note 2: Positive urine cotinine at screening is allowed if negative at check-in (Day -1).
- History of binge drinking or heavy drinking of alcohol at any time in the 6 months before study product administration.
Note 1: Binge drinking is defined as 5 or more drinks during single occasion if male, or 4 or more if female.
Note 2: Heavy drinking of alcohol is defined as consumption of more than 15 units of alcohol per week if male, or more than 8 units if female.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) or placebo administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
N= 8
|
Placebo
A 1-beta methyl-carbapenem that is structurally related to beta-lactam antibiotics
A combination of ertapenem (ERT) and zidebactam (ZID)
A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class
|
Experimental: Cohort 2
Ertapenem 2 g or placebo administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
N=8
|
Placebo
A 1-beta methyl-carbapenem that is structurally related to beta-lactam antibiotics
|
Experimental: Cohort 3
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
N=6
|
A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class
|
Experimental: Cohort 4
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) or placebo administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
N=8
|
Placebo
A 1-beta methyl-carbapenem that is structurally related to beta-lactam antibiotics
A combination of ertapenem (ERT) and zidebactam (ZID)
A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class
|
Experimental: Cohort 5
Ertapenem 3 g or placebo administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
N=8
|
Placebo
A 1-beta methyl-carbapenem that is structurally related to beta-lactam antibiotics
|
Experimental: Cohort 6
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
N=6
|
A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class
|
Experimental: Cohort 7
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) or placebo administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
N=8
|
Placebo
A 1-beta methyl-carbapenem that is structurally related to beta-lactam antibiotics
A combination of ertapenem (ERT) and zidebactam (ZID)
A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment-emergent adverse events (AEs)
Time Frame: Day 1 through Day 11
|
Day 1 through Day 11
|
Incidence of treatment-emergent serious adverse events (SAEs)
Time Frame: Day 1 through Day 11
|
Day 1 through Day 11
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Calculated exposure in plasma for Ertapenem (ERT)
Time Frame: Day 1 through Day 8
|
Day 1 through Day 8
|
Calculated exposure in plasma for Zidebactam (ZID)
Time Frame: Day 1 through Day 8
|
Day 1 through Day 8
|
Calculated exposure in urine for Ertapenem (ERT)
Time Frame: Day 1 through Day 8
|
Day 1 through Day 8
|
Calculated exposure in urine for Zidebactam (ZID)
Time Frame: Day 1 through Day 8
|
Day 1 through Day 8
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-0013
- HHSN272201500005I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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