Safety Study of Intravenous Ertapenem in Combination With... | NCT05645757 | Trialant
NCT05645757
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
Jan 20, 2025Actual
Enrollment
54Actual
Phase
Phase 1
Conditions
Bacterial Infection
Interventions
Ertapenem
Placebo
WCK 6777
Zidebactam
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05645757
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
21-0013
Secondary IDs
Not provided
Brief Title
Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
Official Title
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
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Sep 22, 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 19, 2023Actual
Primary Completion Date
Nov 3, 2023Actual
Completion Date
Nov 3, 2023Actual
First Submitted Date
Dec 1, 2022
First Submission Date that Met QC Criteria
Dec 1, 2022
First Posted Date
Dec 9, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Oct 24, 2024
Results First Submitted that Met QC Criteria
Nov 27, 2024
Results First Posted Date
Dec 5, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 26, 2024
Last Update Posted Date
Jan 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107) alone in 52 healthy adult male and female subjects aged 18 to 45 years old (both inclusive). Seven treatment cohorts will be evaluated in this study. WCK 6777 will be evaluated in three cohorts - Cohorts 1, 4 and 7- of 8 subjects each (6 study drug combinations and 2 placebos); ERT will be evaluated alone in two cohorts - Cohorts 2 and 5- of 8 subject each (6 ERT and 2 placebos); and ZID will be evaluated in two cohorts, Cohorts 3 and 6, of 6 subjects each (all ZID). The study will be placebo-controlled and double-blinded in all cohorts except Cohorts 3 and 6. No placebo subjects are included in standalone ZID cohorts, since adequate safety data for higher doses of ZID alone in comparison with placebo are available from completed Phase 1 studies of WCK 5107 (ZID) alone and the ZID-only arms of WCK 5222 (cefepime + ZID) studies. The primary objective is to assess the safety and tolerability of three dose-escalating regimens of WCK 6777 ( ERT and ZID combination) and two-dose escalating regimens of standalone ERT or ZID following single daily doses for 7 days in healthy adult subjects.
Detailed Description
This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107) alone in 52 healthy adult male and female subjects aged 18 to 45 years old (both inclusive). Seven treatment cohorts will be evaluated in this study. WCK 6777 will be evaluated in three cohorts - Cohorts 1, 4 and 7- of 8 subjects each (6 study drug combinations and 2 placebos); ERT will be evaluated alone in two cohorts - Cohorts 2 and 5- of 8 subject each (6 ERT and 2 placebos); and ZID will be evaluated in two cohorts, Cohorts 3 and 6, of 6 subjects each (all ZID). The study will be placebo-controlled and double-blinded in all cohorts except Cohorts 3 and 6. No placebo subjects are included in standalone ZID cohorts, since adequate safety data for higher doses of ZID alone in comparison with placebo are available from completed Phase 1 studies of WCK 5107 (ZID) alone and the ZID-only arms of WCK 5222 (cefepime + ZID) studies. In each cohort, either study drugs alone or their combination will be administered by a single intravenous infusion (IV) of 100 mL daily for 7 consecutive days in Cohort 1 or 250 mL daily for 7 consecutive days in Cohorts 2 to 7. For each treatment cohort, however, the dose will be progressively escalated from 1 g/daily to 2 g/daily and to 3 g/daily, and the duration of infusion time increased from 30 min to 1 h and to 2 h over the course of the study. In Cohort 1, WCK 6777 2 g (ERT 1 g/daily combined with ZID 1 g/daily) will be administered in 30 (±5) minutes (min); in Cohort 2 (ERT 2 g/daily), Cohort 3 (ZID 2 g/daily), and Cohort 4 (WCK 6777 4 g [ERT 2 g/daily combined with ZID 2 g/daily]) the study drug(s) will be administered in 60 (±10) min, and in Cohort 5 (ERT 3 g/daily), Cohort 6 (ZID 3 g daily) and Cohort 7 (WCK 6777 6 g [ERT 3 g/daily combined with ZID 3 g/daily]), the study drug(s) will be administered in 120 (±10) min. The primary objective is to assess the safety and tolerability of three dose-escalating regimens of WCK 6777 ( ERT and ZID combination) and two-dose escalating regimens of standalone ERT or ZID following single daily doses for 7 days in healthy adult subjects. The secondary objective is to characterize the PK profiles in plasma (total & free) and in urine of three dose-escalating regimens of WCK 6777 (ERT and ZID combination) and two dose-escalating regimens of standalone ERT or ZID following a single initial dose on Day 1 and after single daily doses for 7 days in healthy adult subjects.
Conditions Module
Conditions
Bacterial Infection
Keywords
Double-blind
Intravenous Ertapenem
Phase 1
Safety
Zidebactam (WCK 6777)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
54Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
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
Drug: Ertapenem
Other: Placebo
Drug: WCK 6777
Drug: Zidebactam
Cohort 2
Experimental
Ertapenem 2 g or placebo administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days. N=8
Drug: Ertapenem
Other: Placebo
Cohort 3
Experimental
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days. N=6
Drug: Zidebactam
Cohort 4
Experimental
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
Drug: Ertapenem
Other: Placebo
Drug: WCK 6777
Drug: Zidebactam
Cohort 5
Experimental
Ertapenem 3 g or placebo administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. N=8
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ertapenem
Drug
A 1-beta methyl-carbapenem that is structurally related to beta-lactam antibiotics
Cohort 1
Cohort 2
Cohort 4
Cohort 5
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events
Adverse events (AEs) are defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, regardless of its causal relationship to the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of the product, and are described as treatment-emergent AEs (TEAEs). Number of participants with a TEAE are summarized by dose group and by MedDRA System Organ Class (SOC).
Day 1 through Day 11
Number of Treatment-Emergent Adverse Events Reported
Adverse events (AEs) are defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, regardless of its causal relationship to the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of the product, and are described as treatment-emergent AEs (TEAEs). Number of TEAEs reported are summarized by dose group and MedDRA System Organ Class (SOC)..
Day 1 through Day 11
Number of Participants With Treatment-Emergent Adverse Events Related to Study Product
Adverse events (AEs) are defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, regardless of its causal relationship to the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of the product, and are described as treatment-emergent AEs (TEAEs). TEAEs are assessed by the investigator to determine relationship to the study drug. Number of participants with a related TEAE are summarized by dose group and by MedDRA System Organ Class (SOC).
Day 1 through Day 11
Number of Serious Adverse Events Reported
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Concentration (Cmax) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmax (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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 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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
45 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Altasciences Inc - Kansas City
Overland Park
Kansas
66212
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Participants were recruited between 19APR2023 and 24OCT2023 by the clinical trials unit (CTU) utilizing the CTU subject database and IRB-approved advertisements and social media.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
WCK 6777: A combination of ertapenem (ERT) and zidebactam (ZID)
FG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
FG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
FG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
WCK 6777: A combination of ertapenem (ERT) and zidebactam (ZID)
FG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
FG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
FG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
WCK 6777: A combination of ertapenem (ERT) and zidebactam (ZID)
FG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0047 subjects
FG0057 subjects
FG0066 subjects
FG00710 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Enrolled but treatment not administered
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
WCK 6777: A combination of ertapenem (ERT) and zidebactam (ZID)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-Emergent Adverse Events
Adverse events (AEs) are defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, regardless of its causal relationship to the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of the product, and are described as treatment-emergent AEs (TEAEs). Number of participants with a TEAE are summarized by dose group and by MedDRA System Organ Class (SOC).
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
Adverse Events Module
Frequency Threshold
5
Time Frame
AEs were documented from the time of starting study drug administration through the time of Final Visit (Day 11 + 3 days)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
All investigative site personnel, study volunteers, DMID, Wockhardt and DVC personnel will remain blinded through database lock, with the exception of an unblinded pharmacist/verifier at the research site, an unblinded SDCC biostatistician, and a DMID/CMS manager responsible for PK sample storage.
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: Ertapenem
Other: Placebo
Cohort 6
Experimental
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. N=6
Drug: Zidebactam
Cohort 7
Experimental
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
Drug: Ertapenem
Other: Placebo
Drug: WCK 6777
Drug: Zidebactam
Cohort 7
Placebo
Other
Placebo
Cohort 1
Cohort 2
Cohort 4
Cohort 5
Cohort 7
WCK 6777
Drug
A combination of ertapenem (ERT) and zidebactam (ZID)
Cohort 1
Cohort 4
Cohort 7
Zidebactam
Drug
A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class
Cohort 1
Cohort 3
Cohort 4
Cohort 6
Cohort 7
Serious AEs (SAEs) meet one or more of the following criteria: death, life-threatening AEs, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, substantial disruption of the ability to conduct normal life function, congenital anomaly/birth defect, or important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. SAEs are listed.
Day 1 through Day 11
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results
Parameters and thresholds include alanine aminotransferase =33 (female (F) 19Y), =30 (F >19) or =47 U/L (male (M) =19Y); albumin =3.5 g/dL; alkaline phosphatase =129 (F 19Y), =126 (F =49Y), =170 (M 19Y) or =131 U/L (M =49Y); aspartate aminotransferase =33 (19Y) or =41 U/L (20-49Y); bilirubin =1.2 (19Y) or =1.3 mg/dL (>19Y); calcium =8.8 (4-19Y), =8.5 (20-49Y), =10.5 (4-19Y), =10.3 (F 20-49Y) or =10.4 mg/dL (M 20-49Y); carbon dioxide =19 or =33 mmol/L; creatinine =0.97 (F 18-29Y), =0.98 (F 30-39Y), =1.00 (F 40-49Y), =1.25 (M 18-29Y), =1.27 (M 30-39Y) or =1.30 mg/dL (M 40-49Y); direct bilirubin =0.3 mg/dL; glucose =64 or =100 mg/dL; potassium =3.7 (19Y), =3.4 (>19Y), = 5.2 (19Y) or = 5.4 mmol/L (>19Y); protein =6.2 (19Y) or =6.0 g/dL (>19Y); sodium =134 or =147 mmol/L; and urea nitrogen =21 (19Y) or =26 mg/dL (>19Y). All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Day 1 through Day 11
Number of Participants With Abnormal Hematology Laboratory Toxicity Results
Parameters and thresholds include basophils =201 x106/L (>6Y); eosinophils =501 x106/L (>6Y); hemoglobin =11.4 (female (F) 18Y), =11.6 (F >18Y), =11.9 (male (M) 18Y) or =13.1 g/dL (M >18Y); leukocytes =4.4 (18Y), =3.7 (>18Y), =13.1 (18Y) or =10.9 x109/L (>18Y); lymphocytes =1199 (18Y) or =849 x106/L (>18Y); monocytes =901 (18Y) or =951 x106/L (>18Y); neutrophils =1799 (18Y) or =1499 x106/L (>18Y); and platelets <140 x109/L. All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Day 1 through Day 11
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results
Parameters and thresholds include activated partial thromboplastin time >32 s, prothrombin intl. normalized ratio >1.1 (ratio), and prothrombin time >11.5 s. All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Day 1 through Day 11
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results
Parameters and thresholds include dipstick measurements of glucose =1+, leukocyte esterase =1+, occult blood =1+, protein =1+ and urinalysis with microscopy results of at least a few bacteria, red blood cells (RBC) =3 per high-powered field (HPF), and white blood cells (WBC) =6 per HPF. If dipstick results were abnormal, urinalysis with microscopy was performed. All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Day 1 through Day 11
Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results
The only ECG parameters graded were PR interval with a threshold of =211 msec and QTcF interval with a threshold of =471 msec (female) or =451 msec (male) or an increase of =30 msec above baseline. ECG values after dosing were considered as TEAEs if they met toxicity grading criteria.
Day 8 and Day 11
Number of Participants With Abnormal Vital Signs (VS)
VS parameters and thresholds include diastolic blood pressure =90 mmHg, oral temperature =37.3 °C, pulse =49 or =101 beats/min, respiratory rate =21 breaths/min, and systolic blood pressure =88 or =131 mmHg. VS could be repeated up to twice more at rest and within at least 5 minutes of each other. The following rules were used to determine which vital sign measurement to use for analysis if repeat measurements occurred: 1. If the first replicate was normal, it was used. 2. If the first and second replicates were both abnormal, the replicate with the higher severity was used. 3. If the first replicate was abnormal, the second replicate was normal, and the third replicate was not performed, the first replicate was used. 4. If the first replicate was abnormal and the second and third replicates were normal, the second replicate was used. 5. If the first and third replicates were abnormal and the second replicate was normal, the abnormal replicate with the higher severity was used.
Day 1 through Day 11
Minimum Observed Concentration (Cmin) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmin (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Predicted Concentration at the End of the Dosing Interval (Ctau) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Ctau (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group. Ctau is estimated using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Dose-Normalized Maximum Observed Concentration (Cmax/Dose) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized Cmax ((µg/mL)/mg) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Time of Maximum Concentration (Tmax) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmax (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Time of Minimum Concentration (Tmin) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmin (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Area Under the Concentration-Time Curve From Dosing to the Predicted Time the Concentration Reaches the Lower Limit of Quantification (AUC(0-t)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) extrapolated to the time the concentration is predicted to reach the lower limit of quantification (LLOQ), AUC(0-t) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Area Under the Concentration-Time Curve From Dosing to Time of the Last Measured Concentration (AUC(0-last)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) to the time of last measured concentration, AUC(0-last) (µg*h/mL),parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Area Under the Concentration-Time Curve From Dosing Taken to the Limit as the End Time Becomes Arbitrarily Large (AUC(0-inf)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) taken to the limit as the end time becomes arbitrarily large, AUC(0-inf) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Area Under the Concentration-Time Curve From Dosing Extrapolated to 24 Hours After Dosing (AUC(0-24)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) extrapolated to 24 h after dosing, AUC(0-24) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Area Under the Concentration-Time Curve From Dosing to the End of the Dosing Interval (AUC(0-tau)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion), AUC(0-tau) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Dose-Normalized Area Under the Concentration-Time Curve From Dosing to the End of the Dosing Interval (AUC(0-tau)/Dose) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized total area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion), AUC(0-tau)/Dose ((µg*h/mL)/mg), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Terminal Elimination Half-Life (t1/2) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the terminal elimination half-life, t1/2 (h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Total Clearance (CLT) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total clearance, CLT (L/h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
First-Order Terminal Phase Elimination Rate Constant (Ke) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the first-order terminal phase elimination rate constant, Ke (1/h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Apparent Volume of Distribution (Vd) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the apparent volume of distribution, Vd (L), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
Maximum Observed Concentration at Steady State (Cmax,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmax,ss (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. These estimates assume steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Minimum Observed Concentration at Steady State (Cmin,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmin,ss (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. These estimates assume steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Dose-Normalized Maximum Observed Concentration at Steady State (Cmax,ss/Dose) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized Cmax,ss ((µg/mL)/mg) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. This estimate assumes steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Average Concentration Over the Dose 7 Dosing Interval (Cavg) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the average concentration over the Dose 7 dosing interval, Cavg (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). Cavg is calculated as AUC(0-tau,ss)/tau. These estimates assume steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Predicted Concentration at the End of the Dosing Interval at Steady State (Ctau,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the predicted concentration at the end of the dosing interval at steady state, Ctau,ss (µg/mL), parameters estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). These estimates assume steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Time of Maximum Concentration at Steady State (Tmax,ss) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmax,ss (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. The estimate for Tmax,ss assumes steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Time of Minimum Concentration (Tmin) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmin (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Area Under the Concentration-Time Curve From Dose 7 Dosing Extrapolated to 24 Hours After Dosing at Steady State (AUC(0-24),ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the area under the concentration-time curve from dosing (time 0 h) extrapolated to 24 h after dosing at steady state, AUC(0-24),ss (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Area Under the Concentration-Time Curve From Dose 7 Dosing to the End of the Dosing Interval at Steady State (AUC(0-tau),ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion) at steady state, AUC(0-tau),ss (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Dose-Normalized Area Under the Concentration-Time Curve From Dose 7 Dosing to the End of the Dosing Interval at Steady State (AUC(0-tau),ss/Dose) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized total area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion) at steady state, AUC(0-tau),ss/Dose ((µg*h/mL)/mg), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Terminal Elimination Half-Life (t1/2) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the terminal elimination half-life, t1/2 (h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Total Clearance (CLT) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total clearance, CLT (L/h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Apparent Volume of Distribution at Steady State (Vd,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the apparent volume of distribution at steady state, Vd,ss (L), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
Linearity Index of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the linearity index (ratio) for the total ERT, free ERT, total ZID, and free ZID plasma concentration-time data by dose group. The linearity index is a measure of how linear the relationship is between increase in administered dose and increase in exposure. The linearity index is estimated as AUC(0-tau),ss (Dose 7)/AUC(0-inf) (Dose 1), where the areas under the concentration-time curves from Dose 7 to the end of the dosing interval at steady state and from Dose 1 taken to the limit as the end time becomes arbitrarily large, AUC(0-tau),ss and AUC(0-inf) respectively, are calculated using Phoenix WinNonlin Non-compartmental Analysis with Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). The AUC(0-tau),ss estimate assumes steady state was reached.
=0.5 h prior to the start of and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) and Dose 7 (Day 7) infusions
The Accumulation Ratio of the Area Under the Concentration-Time Curve (RAUC) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the accumulation ratio of the AUC, RAUC (ratio), parameter for the total ERT, free ERT, total ZID, and free ZID plasma concentration-time data by dose group. RAUC is estimated as AUC(0-tau),ss (Dose 7)/AUC(0-24) (Dose 1), where the areas under the concentration-time curves from Dose 7 to the end of the dosing interval at steady state and from Dose 1 extrapolated to 24 h after Dose 1, AUC(0-tau),ss and AUC(0-24) respectively, are calculated using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). The AUC(0-tau),ss estimate assumes steady state was reached.
=0.5 h prior to the start of and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) and Dose 7 (Day 7) infusions
The Accumulation Ratio of the Maximum Observed Concentration (RCmax) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the accumulation ratio of the Cmax, RCmax (ratio), parameter for the total ERT, free ERT, total ZID, and free ZID plasma concentration-time data by dose group. RCmax is estimated as Cmax (Dose 7)/Cmax (Dose 1), where the Cmax parameters are estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h periods following Dose 1 and Dose 7, respectively.
=0.5 h prior to the start of and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) and Dose 7 (Day 7) infusions
Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine (Ae,Urine) During Each Nominal Time Collection Interval Following Dose 1
Mean and minimum/maximum of the amount of unchanged ERT and the amount of unchanged ZID excreted in urine, Ae,urine (mg), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 1 by dose group. Ae,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 (Day 1) infusion
Cumulative Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine From Zero (Predose) to 24 h Following Dose 1 (Ae,Urine(0-24))
Mean and minimum/maximum of the cumulative amount of unchanged ERT and the cumulative amount of unchanged ZID excreted in urine from zero (predose) to 24 h following Dose 1, Ae,urine(0-24) (mg), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-1 h pre-start of Dose 1 (Day 1) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 infusion
Fractions (%) of ERT and ZID Excreted Unchanged in Urine (fe,Urine) During Each Nominal Time Collection Interval Following Dose 1
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine, fe,urine (%), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 1 by dose group. These fe,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 (Day 1) infusion
Fractions (%) of ERT and ZID Excreted Unchanged in Urine From Zero (Predose) to 24 h Following Dose 1 (fe,Urine(0-24))
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine from zero (predose) to 24 h following Dose 1, fe,urine(0-24) (%), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-1 h pre-start of Dose 1 (Day 1) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 infusion
Renal Clearance of ERT and ZID From Dosing Until the Last Collected Concentration for Dose 1 (CLR(0-24))
Geometric mean (GM), and coefficient of variation percentage (CV%) of renal clearance of ERT and ZID from dosing until the last collected concentration for Dose 1 (24 h postdose), CLR(0-24) (mL/h ), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-1 h pre-start of Dose 1 (Day 1) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 infusion
Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine (Ae,Urine) During Each Nominal Time Collection Interval Following Dose 7
Mean and minimum/maximum of the amount of unchanged ERT and the amount of unchanged ZID excreted in urine, Ae,urine (mg), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 7 by dose group. Ae,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 (Day 7) infusion
Cumulative Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine From Zero (Predose) to 24 h Following Dose 7 (Ae,Urine(0-24),SS)
Mean and minimum/maximum of the cumulative amount of unchanged ERT and the cumulative amount of unchanged ZID excreted in urine from zero (predose) to 24 h following Dose 7, Ae,urine(0-24) (mg), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-1 h pre-start of Dose 7 (Day 7) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 infusion
Fractions (%) of ERT and ZID Excreted Unchanged in Urine (fe,Urine) During Each Nominal Time Collection Interval Following Dose 7
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine, fe,urine (%), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 7 by dose group. These fe,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 (Day 7) infusion
Fractions (%) of ERT and ZID Excreted Unchanged in Urine From Zero (Predose) to 24 h Following Dose 7 (fe,Urine(0-24),SS)
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine from zero (predose) to 24 h following Dose 7, fe,urine(0-24) (%), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-1 h pre-start of Dose 7 (Day 7) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 infusion
Renal Clearance of ERT and ZID From Dosing Until the Last Collected Concentration for Dose 7 (CLR(0-24),SS)
Geometric mean (GM), and coefficient of variation percentage (CV%) of renal clearance of ERT and ZID from dosing until the last collected concentration for Dose 7 (24 h postdose), CLR(0-24) (mL/h), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
0-1 h pre-start of Dose 7 (Day 7) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 infusion
6 subjects
FG0056 subjects
FG0066 subjects
FG00710 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
BG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
BG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
BG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
WCK 6777: A combination of ertapenem (ERT) and zidebactam (ZID)
BG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
BG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
BG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Ertapenem: A 1-ß methyl-carbapenem that is structurally related to ß-lactam antibiotics
Zidebactam: A ß-lactamase inhibitor and ß-lactam enhancer from the diazabicyclooctane (DBO) class
WCK 6777: A combination of ertapenem (ERT) and zidebactam (ZID)
BG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
BG008
Total
Total of all reporting groups
6
BG0016
BG0026
BG0036
BG0047
BG0057
BG0066
BG00710
BG00854
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00033.7± 7.3
BG00135.2± 9.2
BG00232.3± 9.5
BG00333.2± 7.0
BG00433.6± 7.9
BG00537.3± 5.6
BG00629.2± 9.0
BG00730.7± 6.7
BG00833.0± 7.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG0022
BG0033
BG0042
BG0052
BG0062
BG0074
BG00820
Male
BG0004
BG0013
BG0024
BG0033
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG0020
BG0031
BG0042
BG0051
BG0060
BG0071
BG0088
Not Hispanic or Latino
BG0004
BG0015
BG0026
BG0035
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0005
BG0014
BG0022
BG0031
BG004
White
BG0000
BG0012
BG0024
BG0035
BG004
More than one race
BG0001
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
BMI
Mean
Standard Deviation
kg/m2
Title
Denominators
Categories
Title
Measurements
BG00027.08± 2.93
BG00128.57± 2.05
BG00225.18± 3.38
BG00327.63± 2.85
BG00423.83± 1.62
BG00527.27± 2.76
BG00624.05± 4.36
BG00726.87± 2.82
BG00826.32± 3.15
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG00710
Title
Denominators
Categories
Blood and lymphatic system disorders
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0061
OG0071
Gastrointestinal disorders
Title
Measurements
OG0002
OG0012
OG0020
OG003
General disorders and administration site conditions
Title
Measurements
OG0003
OG0015
OG0025
OG003
Infections and infestations
Title
Measurements
OG0000
OG0011
OG0020
OG003
Injury, poisoning and procedural complications
Title
Measurements
OG0001
OG0010
OG0020
OG003
Investigations
Title
Measurements
OG0001
OG0010
OG0021
OG003
Musculoskeletal and connective tissue disorders
Title
Measurements
OG0001
OG0010
OG0020
OG003
Nervous system disorders
Title
Measurements
OG0001
OG0011
OG0021
OG003
Renal and urinary disorders
Title
Measurements
OG0000
OG0011
OG0020
OG003
Respiratory, thoracic and mediastinal disorders
Title
Measurements
OG0000
OG0010
OG0021
OG003
Skin and subcutaneous tissue disorders
Title
Measurements
OG0001
OG0010
OG0023
OG003
Primary
Number of Treatment-Emergent Adverse Events Reported
Adverse events (AEs) are defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, regardless of its causal relationship to the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of the product, and are described as treatment-emergent AEs (TEAEs). Number of TEAEs reported are summarized by dose group and MedDRA System Organ Class (SOC)..
Safety Population: All participants that received any amount of study drug(s).
Posted
Number
events
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Blood and lymphatic system disorders
Title
Measurements
OG0000
OG0011
OG0021
OG003
Primary
Number of Participants With Treatment-Emergent Adverse Events Related to Study Product
Adverse events (AEs) are defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, regardless of its causal relationship to the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of the product, and are described as treatment-emergent AEs (TEAEs). TEAEs are assessed by the investigator to determine relationship to the study drug. Number of participants with a related TEAE are summarized by dose group and by MedDRA System Organ Class (SOC).
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Blood and lymphatic system disorders
Title
Measurements
OG0000
OG0011
OG0021
OG003
Primary
Number of Serious Adverse Events Reported
Serious AEs (SAEs) meet one or more of the following criteria: death, life-threatening AEs, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, substantial disruption of the ability to conduct normal life function, congenital anomaly/birth defect, or important medical events that may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. SAEs are listed.
Safety Population: All participants that received any amount of study drug(s).
Posted
Number
events
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results
Parameters and thresholds include alanine aminotransferase =33 (female (F) 19Y), =30 (F >19) or =47 U/L (male (M) =19Y); albumin =3.5 g/dL; alkaline phosphatase =129 (F 19Y), =126 (F =49Y), =170 (M 19Y) or =131 U/L (M =49Y); aspartate aminotransferase =33 (19Y) or =41 U/L (20-49Y); bilirubin =1.2 (19Y) or =1.3 mg/dL (>19Y); calcium =8.8 (4-19Y), =8.5 (20-49Y), =10.5 (4-19Y), =10.3 (F 20-49Y) or =10.4 mg/dL (M 20-49Y); carbon dioxide =19 or =33 mmol/L; creatinine =0.97 (F 18-29Y), =0.98 (F 30-39Y), =1.00 (F 40-49Y), =1.25 (M 18-29Y), =1.27 (M 30-39Y) or =1.30 mg/dL (M 40-49Y); direct bilirubin =0.3 mg/dL; glucose =64 or =100 mg/dL; potassium =3.7 (19Y), =3.4 (>19Y), = 5.2 (19Y) or = 5.4 mmol/L (>19Y); protein =6.2 (19Y) or =6.0 g/dL (>19Y); sodium =134 or =147 mmol/L; and urea nitrogen =21 (19Y) or =26 mg/dL (>19Y). All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Alanine aminotransferase increase
Title
Measurements
OG0000
OG0012
OG0020
OG003
Primary
Number of Participants With Abnormal Hematology Laboratory Toxicity Results
Parameters and thresholds include basophils =201 x106/L (>6Y); eosinophils =501 x106/L (>6Y); hemoglobin =11.4 (female (F) 18Y), =11.6 (F >18Y), =11.9 (male (M) 18Y) or =13.1 g/dL (M >18Y); leukocytes =4.4 (18Y), =3.7 (>18Y), =13.1 (18Y) or =10.9 x109/L (>18Y); lymphocytes =1199 (18Y) or =849 x106/L (>18Y); monocytes =901 (18Y) or =951 x106/L (>18Y); neutrophils =1799 (18Y) or =1499 x106/L (>18Y); and platelets <140 x109/L. All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Basophils increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results
Parameters and thresholds include activated partial thromboplastin time >32 s, prothrombin intl. normalized ratio >1.1 (ratio), and prothrombin time >11.5 s. All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Activated partial thromboplastin time increase
Title
Measurements
OG0001
OG0010
OG0020
OG003
Primary
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results
Parameters and thresholds include dipstick measurements of glucose =1+, leukocyte esterase =1+, occult blood =1+, protein =1+ and urinalysis with microscopy results of at least a few bacteria, red blood cells (RBC) =3 per high-powered field (HPF), and white blood cells (WBC) =6 per HPF. If dipstick results were abnormal, urinalysis with microscopy was performed. All abnormal toxicity results are included, but Grade 1 values at screening/baseline allowed for enrollment were only considered TEAEs if they increased in severity.
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Glucose increase
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results
The only ECG parameters graded were PR interval with a threshold of =211 msec and QTcF interval with a threshold of =471 msec (female) or =451 msec (male) or an increase of =30 msec above baseline. ECG values after dosing were considered as TEAEs if they met toxicity grading criteria.
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 8 and Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
PR interval
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Abnormal Vital Signs (VS)
VS parameters and thresholds include diastolic blood pressure =90 mmHg, oral temperature =37.3 °C, pulse =49 or =101 beats/min, respiratory rate =21 breaths/min, and systolic blood pressure =88 or =131 mmHg. VS could be repeated up to twice more at rest and within at least 5 minutes of each other. The following rules were used to determine which vital sign measurement to use for analysis if repeat measurements occurred: 1. If the first replicate was normal, it was used. 2. If the first and second replicates were both abnormal, the replicate with the higher severity was used. 3. If the first replicate was abnormal, the second replicate was normal, and the third replicate was not performed, the first replicate was used. 4. If the first replicate was abnormal and the second and third replicates were normal, the second replicate was used. 5. If the first and third replicates were abnormal and the second replicate was normal, the abnormal replicate with the higher severity was used.
Safety Population: All participants that received any amount of study drug(s).
Posted
Count of Participants
Participants
Day 1 through Day 11
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Diastolic blood pressure increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Maximum Observed Concentration (Cmax) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmax (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Minimum Observed Concentration (Cmin) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmin (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Predicted Concentration at the End of the Dosing Interval (Ctau) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Ctau (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group. Ctau is estimated using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Dose-Normalized Maximum Observed Concentration (Cmax/Dose) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized Cmax ((µg/mL)/mg) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
(µg/mL)/mg
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Time of Maximum Concentration (Tmax) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmax (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Median
Full Range
hours
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Time of Minimum Concentration (Tmin) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmin (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Median
Full Range
hours
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dosing to the Predicted Time the Concentration Reaches the Lower Limit of Quantification (AUC(0-t)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) extrapolated to the time the concentration is predicted to reach the lower limit of quantification (LLOQ), AUC(0-t) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dosing to Time of the Last Measured Concentration (AUC(0-last)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) to the time of last measured concentration, AUC(0-last) (µg*h/mL),parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dosing Taken to the Limit as the End Time Becomes Arbitrarily Large (AUC(0-inf)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) taken to the limit as the end time becomes arbitrarily large, AUC(0-inf) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dosing Extrapolated to 24 Hours After Dosing (AUC(0-24)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) extrapolated to 24 h after dosing, AUC(0-24) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dosing to the End of the Dosing Interval (AUC(0-tau)) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion), AUC(0-tau) (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Dose-Normalized Area Under the Concentration-Time Curve From Dosing to the End of the Dosing Interval (AUC(0-tau)/Dose) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized total area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion), AUC(0-tau)/Dose ((µg*h/mL)/mg), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
(µg*h/mL)/mg
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Terminal Elimination Half-Life (t1/2) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the terminal elimination half-life, t1/2 (h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Total Clearance (CLT) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total clearance, CLT (L/h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
First-Order Terminal Phase Elimination Rate Constant (Ke) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the first-order terminal phase elimination rate constant, Ke (1/h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
1/h
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Apparent Volume of Distribution (Vd) for Dose 1 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the apparent volume of distribution, Vd (L), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 1 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
=0.5 h prior to dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Maximum Observed Concentration at Steady State (Cmax,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmax,ss (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. These estimates assume steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Minimum Observed Concentration at Steady State (Cmin,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the Cmin,ss (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. These estimates assume steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Dose-Normalized Maximum Observed Concentration at Steady State (Cmax,ss/Dose) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized Cmax,ss ((µg/mL)/mg) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. This estimate assumes steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
(µg/mL)/mg
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Average Concentration Over the Dose 7 Dosing Interval (Cavg) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the average concentration over the Dose 7 dosing interval, Cavg (µg/mL) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). Cavg is calculated as AUC(0-tau,ss)/tau. These estimates assume steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Predicted Concentration at the End of the Dosing Interval at Steady State (Ctau,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the predicted concentration at the end of the dosing interval at steady state, Ctau,ss (µg/mL), parameters estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). These estimates assume steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Time of Maximum Concentration at Steady State (Tmax,ss) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmax,ss (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group. The estimate for Tmax,ss assumes steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Median
Full Range
hours
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Time of Minimum Concentration (Tmin) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Median and minimum/maximum of the Tmin (h) parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Median
Full Range
hours
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dose 7 Dosing Extrapolated to 24 Hours After Dosing at Steady State (AUC(0-24),ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the area under the concentration-time curve from dosing (time 0 h) extrapolated to 24 h after dosing at steady state, AUC(0-24),ss (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Area Under the Concentration-Time Curve From Dose 7 Dosing to the End of the Dosing Interval at Steady State (AUC(0-tau),ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion) at steady state, AUC(0-tau),ss (µg*h/mL), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Dose-Normalized Area Under the Concentration-Time Curve From Dose 7 Dosing to the End of the Dosing Interval at Steady State (AUC(0-tau),ss/Dose) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the dose-normalized total area under the concentration-time curve from dosing (time 0 h) to the end of the dosing interval (24 h post-infusion) at steady state, AUC(0-tau),ss/Dose ((µg*h/mL)/mg), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
(µg*h/mL)/mg
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Terminal Elimination Half-Life (t1/2) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the terminal elimination half-life, t1/2 (h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Total Clearance (CLT) for Dose 7 of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the total clearance, CLT (L/h), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration).
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Apparent Volume of Distribution at Steady State (Vd,ss) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the apparent volume of distribution at steady state, Vd,ss (L), parameter estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h period following Dose 7 by dose group using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). This estimate assumes steady state has been achieved.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
=0.5 h prior to the start of Dose 7 (Day 7) dosing and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Linearity Index of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the linearity index (ratio) for the total ERT, free ERT, total ZID, and free ZID plasma concentration-time data by dose group. The linearity index is a measure of how linear the relationship is between increase in administered dose and increase in exposure. The linearity index is estimated as AUC(0-tau),ss (Dose 7)/AUC(0-inf) (Dose 1), where the areas under the concentration-time curves from Dose 7 to the end of the dosing interval at steady state and from Dose 1 taken to the limit as the end time becomes arbitrarily large, AUC(0-tau),ss and AUC(0-inf) respectively, are calculated using Phoenix WinNonlin Non-compartmental Analysis with Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). The AUC(0-tau),ss estimate assumes steady state was reached.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
=0.5 h prior to the start of and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) and Dose 7 (Day 7) infusions
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
The Accumulation Ratio of the Area Under the Concentration-Time Curve (RAUC) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the accumulation ratio of the AUC, RAUC (ratio), parameter for the total ERT, free ERT, total ZID, and free ZID plasma concentration-time data by dose group. RAUC is estimated as AUC(0-tau),ss (Dose 7)/AUC(0-24) (Dose 1), where the areas under the concentration-time curves from Dose 7 to the end of the dosing interval at steady state and from Dose 1 extrapolated to 24 h after Dose 1, AUC(0-tau),ss and AUC(0-24) respectively, are calculated using Phoenix WinNonlin Non-compartmental Analysis with the Ke (first-order terminal phase elimination rate constant) acceptance criteria: Rsq_adjusted (adjusted R-squared) = 0.90 and includes at least 3 timepoints after Tmax (time of maximum concentration). The AUC(0-tau),ss estimate assumes steady state was reached.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
=0.5 h prior to the start of and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) and Dose 7 (Day 7) infusions
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
The Accumulation Ratio of the Maximum Observed Concentration (RCmax) of Total ERT, Free ERT, Total ZID, and Free ZID in Plasma
Geometric mean (GM), and coefficient of variation percentage (CV%) of the accumulation ratio of the Cmax, RCmax (ratio), parameter for the total ERT, free ERT, total ZID, and free ZID plasma concentration-time data by dose group. RCmax is estimated as Cmax (Dose 7)/Cmax (Dose 1), where the Cmax parameters are estimated from the total ERT, free ERT, total ZID, or free ZID plasma concentration-time data over the 24-h periods following Dose 1 and Dose 7, respectively.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
=0.5 h prior to the start of and 0.25 h (WCK 6777 2g group only), 0.5 h (WCK 6777 2g, ERT 2g, ZID 2g, and WCK 6777 4g groups only), 1 h, 2 h, 3 h, 4 h, 8 h, 12 h, 18 h, and 24 h post-start of Dose 1 (Day 1) and Dose 7 (Day 7) infusions
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Total ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine (Ae,Urine) During Each Nominal Time Collection Interval Following Dose 1
Mean and minimum/maximum of the amount of unchanged ERT and the amount of unchanged ZID excreted in urine, Ae,urine (mg), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 1 by dose group. Ae,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
mg
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT - 0-4 h
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG003
Secondary
Cumulative Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine From Zero (Predose) to 24 h Following Dose 1 (Ae,Urine(0-24))
Mean and minimum/maximum of the cumulative amount of unchanged ERT and the cumulative amount of unchanged ZID excreted in urine from zero (predose) to 24 h following Dose 1, Ae,urine(0-24) (mg), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
mg
0-1 h pre-start of Dose 1 (Day 1) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Fractions (%) of ERT and ZID Excreted Unchanged in Urine (fe,Urine) During Each Nominal Time Collection Interval Following Dose 1
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine, fe,urine (%), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 1 by dose group. These fe,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
% of dose excreted unchanged
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 (Day 1) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT- 0-4 h
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG003
Secondary
Fractions (%) of ERT and ZID Excreted Unchanged in Urine From Zero (Predose) to 24 h Following Dose 1 (fe,Urine(0-24))
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine from zero (predose) to 24 h following Dose 1, fe,urine(0-24) (%), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
% of dose excreted unchanged
0-1 h pre-start of Dose 1 (Day 1) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Renal Clearance of ERT and ZID From Dosing Until the Last Collected Concentration for Dose 1 (CLR(0-24))
Geometric mean (GM), and coefficient of variation percentage (CV%) of renal clearance of ERT and ZID from dosing until the last collected concentration for Dose 1 (24 h postdose), CLR(0-24) (mL/h ), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
0-1 h pre-start of Dose 1 (Day 1) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 1 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine (Ae,Urine) During Each Nominal Time Collection Interval Following Dose 7
Mean and minimum/maximum of the amount of unchanged ERT and the amount of unchanged ZID excreted in urine, Ae,urine (mg), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 7 by dose group. Ae,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
mg
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 (Day 7) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT - 0-4 h
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG003
Secondary
Cumulative Amounts of Unchanged ERT and Unchanged ZID Excreted in Urine From Zero (Predose) to 24 h Following Dose 7 (Ae,Urine(0-24),SS)
Mean and minimum/maximum of the cumulative amount of unchanged ERT and the cumulative amount of unchanged ZID excreted in urine from zero (predose) to 24 h following Dose 7, Ae,urine(0-24) (mg), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
mg
0-1 h pre-start of Dose 7 (Day 7) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Fractions (%) of ERT and ZID Excreted Unchanged in Urine (fe,Urine) During Each Nominal Time Collection Interval Following Dose 7
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine, fe,urine (%), during 0-4 h, 4-8 h, 8-12 h, and 12-24 h following Dose 7 by dose group. These fe,urine parameters are calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
% of dose excreted unchanged
0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 (Day 7) infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT - 0-4 h
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG003
Secondary
Fractions (%) of ERT and ZID Excreted Unchanged in Urine From Zero (Predose) to 24 h Following Dose 7 (fe,Urine(0-24),SS)
Mean and minimum/maximum of the fraction of ERT and the fraction of ZID excreted unchanged in urine from zero (predose) to 24 h following Dose 7, fe,urine(0-24) (%), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Mean
Full Range
% of dose excreted unchanged
0-1 h pre-start of Dose 7 (Day 7) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
Secondary
Renal Clearance of ERT and ZID From Dosing Until the Last Collected Concentration for Dose 7 (CLR(0-24),SS)
Geometric mean (GM), and coefficient of variation percentage (CV%) of renal clearance of ERT and ZID from dosing until the last collected concentration for Dose 7 (24 h postdose), CLR(0-24) (mL/h), by dose group. This parameter is calculated using a combination of Phoenix WinNonlin and SAS version 9.4 or above.
PK Analysis Subset Population: all participants who received the intended dose of study drug(s) on the given day(s) of analysis, have at least one quantifiable post-dosing plasma drug concentration measured, and have sufficient data that permit estimation of PK parameters. Any participant with at least one estimable PK parameter is included in this subset.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
0-1 h pre-start of Dose 7 (Day 7) infusion and 0-4 h, 4-8 h, 8-12 h, and 12-24 h post-start of Dose 7 infusion
ID
Title
Description
OG000
Cohort 1 - WCK 6777 2 g
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days.
OG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
OG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
OG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
OG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
OG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Unchanged ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG003
0
6
0
6
6
6
EG001
Cohort 2 - ERT 2 g
Ertapenem 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days.
0
6
0
6
6
6
EG002
Cohort 3 - ZID 2 g
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days.
0
6
0
6
5
6
EG003
Cohort 4 - WCK 6777 4 g
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days.
0
6
0
6
5
6
EG004
Cohort 5 - ERT 3 g
Ertapenem 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
0
6
0
6
4
6
EG005
Cohort 6 - ZID 3 g
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
0
6
0
6
2
6
EG006
Cohort 7 - WCK 6777 6 g
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days.
0
6
0
6
4
6
EG007
Placebo
Placebo participants from Cohorts 1,2,4,5,7. Placebo administered corresponding to method for active drug administration in each cohort.
0
10
0
10
9
10
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected10 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected10 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA 26.1
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected10 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Infusion site erythema
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events2 affected6 at risk
EG0023 events3 affected6 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected6 at risk
EG0071 events1 affected10 at risk
Infusion site extravasation
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0032 events2 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0074 events3 affected10 at risk
Infusion site haemorrhage
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0075 events3 affected10 at risk
Infusion site oedema
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected10 at risk
Infusion site pain
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Infusion site papule
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Infusion site phlebitis
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected10 at risk
Infusion site pruritus
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Infusion site swelling
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0072 events2 affected10 at risk
Injection site haemorrhage
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected10 at risk
Injection site phlebitis
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Pyrexia
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Vessel puncture site bruise
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Vessel puncture site pain
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Vessel puncture site phlebitis
General disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Viral infection
Infections and infestations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Blood pressure increased
Investigations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Blood pressure systolic increased
Investigations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected10 at risk
Body temperature increased
Investigations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected10 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Heart rate decreased
Investigations
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected10 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Headache
Nervous system disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected10 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected10 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected10 at risk
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Organic Chemicals
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
5
BG0055
BG0064
BG0076
BG00834
5
BG0056
BG0066
BG0079
BG00846
0
BG0050
BG0060
BG0070
BG0080
0
BG0050
BG0060
BG0070
BG0080
1
BG0050
BG0060
BG0070
BG0081
2
BG0052
BG0065
BG0077
BG00828
4
BG0055
BG0061
BG0072
BG00823
0
BG0050
BG0060
BG0070
BG0081
0
BG0050
BG0060
BG0071
BG0081
1
OG0041
OG0050
OG0061
OG0071
4
OG0044
OG0052
OG0063
OG0076
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0061
OG0073
0
OG0040
OG0051
OG0060
OG0070
0
OG0041
OG0050
OG0060
OG0072
1
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0070
0
OG0040
OG0050
OG0060
OG0071
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0050
OG0061
OG0071
Gastrointestinal disorders
Title
Measurements
OG0003
OG0012
OG0020
OG0031
OG0041
OG0050
OG0061
OG0071
General disorders and administration site conditions
Title
Measurements
OG0006
OG00111
OG0028
OG0036
OG0046
OG0053
OG0066
OG00714
Infections and infestations
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Injury, poisoning and procedural complications
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Investigations
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0042
OG0050
OG0061
OG0073
Musculoskeletal and connective tissue disorders
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
Nervous system disorders
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
OG0072
Renal and urinary disorders
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
Respiratory, thoracic and mediastinal disorders
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
Skin and subcutaneous tissue disorders
Title
Measurements
OG0001
OG0010
OG0023
OG0030
OG0040
OG0050
OG0060
OG0071
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0050
OG0061
OG0071
Gastrointestinal disorders
Title
Measurements
OG0002
OG0012
OG0020
OG0031
OG0041
OG0050
OG0061
OG0071
General disorders and administration site conditions
Title
Measurements
OG0003
OG0015
OG0024
OG0033
OG0042
OG0052
OG0063
OG0074
Infections and infestations
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Injury, poisoning and procedural complications
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Investigations
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0050
OG0061
OG0072
Musculoskeletal and connective tissue disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Nervous system disorders
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
OG0072
Renal and urinary disorders
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
Respiratory, thoracic and mediastinal disorders
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
Skin and subcutaneous tissue disorders
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0066
OG00710
2
OG0042
OG0050
OG0061
OG0071
Albumin decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
Alkaline phosphatase increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Aspartate aminotransferase increase
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0041
OG0050
OG0060
OG0070
Bilirubin increase
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
Calcium decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0071
Calcium increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Carbon dioxide decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Carbon dioxide increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0070
Creatinine increase
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0040
OG0050
OG0060
OG0070
Direct bilirubin increase
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
Glucose decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Glucose increase
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0040
OG0050
OG0060
OG0071
Potassium decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Potassium increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Protein decrease
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0040
OG0050
OG0060
OG0070
Sodium decrease
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0041
OG0051
OG0060
OG0071
Sodium increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Urea nitrogen increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0050
OG0060
OG0070
Eosinophils increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Hemoglobin decrease
Title
Measurements
OG0003
OG0012
OG0022
OG0032
OG0042
OG0052
OG0062
OG0075
Leukocytes decrease
Title
Measurements
OG0003
OG0010
OG0020
OG0032
OG0042
OG0050
OG0063
OG0072
Leukocytes increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Lymphocytes decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Monocytes increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Neutrophils decrease
Title
Measurements
OG0001
OG0010
OG0020
OG0032
OG0041
OG0050
OG0062
OG0072
Platelets decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0051
OG0060
OG0070
Prothrombin intl. normalized ratio (INR) increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
Prothrombin time increase
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0071
6
OG0046
OG0056
OG0066
OG00710
6
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Leukocyte esterase increase
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
Title
Measurements
OG0001
OG0011
OG0021
OG003
Occult blood increase
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
Title
Measurements
OG0001
OG0012
OG0020
OG003
Protein increase
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG00710
Title
Measurements
OG0000
OG0011
OG0020
OG003
RBC increase
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0073
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBC increase
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0073
Title
Measurements
OG0001
OG0012
OG0020
OG003
Bacteria increase
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0032
ParticipantsOG0040
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0073
Title
Measurements
OG0001
OG0010
OG0021
OG003
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0050
OG0060
OG0070
QTcF interval
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0066
OG00710
0
OG0040
OG0050
OG0060
OG0070
Oral temperature increase
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0061
OG0072
Pulse decrease
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0062
OG0070
Pulse increase
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
Respiratory rate increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Systolic blood pressure decrease
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Systolic blood pressure increase
Title
Measurements
OG0002
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
OG0071
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000196.66± 14
OG001303.43± 9
OG003354.41± 8
OG004378.71± 10
OG006391.87± 13
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00016.60± 17
OG00134.00± 17
OG00342.10± 22
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00069.67± 15
OG002120.41± 22
OG003133.51± 16
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00064.35± 20
OG002105.42± 16
OG00398.41± 55
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0002.15± 50
OG0012.61± 107
OG0033.10± 60
OG0047.32± 14
OG0065.91± 33
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.10± 40
OG0010.16± 42
OG0030.14± 67
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.09± 37
OG0020.11± 72
OG0030.10± 44
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.09± 22
OG0020.07± 36
OG0030.10± 39
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0002.02± 50
OG0012.29± 112
OG0032.83± 61
OG0046.83± 16
OG0065.44± 34
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.08± 39
OG0010.10± 102
OG0030.13± 67
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.02± 101
OG0020.06± 69
OG0030.05± 87
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.04± 102
OG0020.06± 49
OG0030.05± 96
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.20± 14
OG0010.15± 9
OG0030.18± 8
OG0040.13± 10
OG0060.13± 14
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.02± 17
OG0010.02± 17
OG0030.02± 22
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.07± 15
OG0020.06± 22
OG0030.07± 16
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.06± 20
OG0020.05± 16
OG0030.05± 55
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.50(0.50 to 0.50)
OG0011.00(1.00 to 1.07)
OG0031.00(1.00 to 1.00)
OG0042.02(2.00 to 2.03)
OG0062.03(2.02 to 2.03)
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.50(0.50 to 0.50)
OG0011.00(1.00 to 1.07)
OG0031.00(1.00 to 1.00)
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.50(0.50 to 0.50)
OG0021.03(1.02 to 1.03)
OG0031.00(1.00 to 1.00)
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.50(0.50 to 0.50)
OG0021.03(1.02 to 1.03)
OG0031.00(1.00 to 2.00)
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00023.60(23.60 to 23.70)
OG00123.65(23.60 to 23.70)
OG00323.60(23.60 to 23.60)
OG00423.60(23.40 to 23.60)
OG00623.60(23.60 to 23.70)
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00023.60(18.00 to 23.60)
OG00123.60(18.00 to 23.70)
OG00323.60(23.60 to 23.60)
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00018.00(18.00 to 23.60)
OG00223.60(18.00 to 23.70)
OG00323.60(18.00 to 23.60)
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00023.60(18.00 to 23.70)
OG00223.60(23.60 to 23.70)
OG00323.60(18.00 to 23.60)
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000723.48± 9
OG0011241.47± 18
OG0031377.99± 14
OG0042148.23± 11
OG0062024.46± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00039.92± 7
OG00183.95± 19
OG003102.81± 24
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000140.00± 8
OG002302.40± 18
OG003320.50± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000125.17± 8
OG002257.74± 15
OG003247.40± 42
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000728.18± 9
OG0011247.86± 18
OG0031384.69± 14
OG0042153.20± 11
OG0062027.57± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00041.04± 7
OG00185.03± 19
OG003103.94± 23
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000141.17± 8
OG002303.42± 18
OG003321.35± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000126.34± 8
OG002259.11± 15
OG003248.60± 42
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000742.95± 10
OG0011265.39± 19
OG0031404.86± 15
OG0042199.93± 11
OG0062065.37± 11
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00041.65± 7
OG00185.93± 19
OG003104.94± 24
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000141.33± 8
OG002303.92± 18
OG003322.04± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000126.50± 8
OG002259.27± 15
OG003249.11± 41
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000728.97± 9
OG0011249.60± 18
OG0031386.28± 14
OG0042156.38± 11
OG0062029.12± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00041.19± 7
OG00185.25± 19
OG003103.96± 23
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000141.17± 8
OG002303.60± 18
OG003321.76± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000126.34± 8
OG002259.11± 15
OG003248.60± 42
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000728.97± 9
OG0011249.60± 18
OG0031386.28± 14
OG0042156.38± 11
OG0062029.12± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00041.19± 7
OG00185.25± 19
OG003103.96± 23
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000141.17± 8
OG002303.60± 18
OG003321.76± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000126.34± 8
OG002259.11± 15
OG003248.60± 42
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.73± 9
OG0010.62± 18
OG0030.69± 15
OG0040.72± 11
OG0060.68± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.04± 7
OG0010.04± 19
OG0030.05± 24
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.14± 8
OG0020.15± 18
OG0030.16± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.13± 8
OG0020.13± 15
OG0030.12± 41
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0004.34± 12
OG0013.76± 22
OG0033.92± 14
OG0044.20± 4
OG0064.20± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0004.09± 11
OG0013.83± 21
OG0033.86± 15
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0002.35± 15
OG0022.60± 14
OG0032.57± 12
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0002.75± 18
OG0022.81± 14
OG0032.63± 15
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0001.34± 10
OG0011.58± 19
OG0031.42± 15
OG0041.37± 11
OG0061.45± 11
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00023.99± 7
OG00123.28± 19
OG00319.06± 24
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0007.07± 8
OG0026.58± 18
OG0036.21± 20
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0007.91± 8
OG0027.71± 15
OG0038.03± 41
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.16± 12
OG0010.18± 22
OG0030.18± 14
OG0040.17± 4
OG0060.17± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.17± 11
OG0010.18± 21
OG0030.18± 15
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.30± 15
OG0020.27± 14
OG0030.27± 12
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.25± 18
OG0020.25± 14
OG0030.26± 14
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0008.43± 7
OG0018.57± 9
OG0038.04± 12
OG0048.28± 10
OG0068.81± 13
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000141.43± 11
OG001128.25± 12
OG003106.20± 23
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00023.97± 14
OG00224.67± 28
OG00323.05± 22
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00031.37± 12
OG00231.18± 23
OG00330.42± 40
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000181.90± 11
OG001341.92± 10
OG003344.89± 10
OG004387.57± 9
OG006343.24± 13
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00015.41± 24
OG00138.18± 13
OG00336.09± 23
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00063.87± 17
OG002115.71± 16
OG003130.69± 18
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00057.89± 23
OG002103.12± 18
OG00383.36± 57
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0001.75± 30
OG0011.81± 114
OG0031.74± 75
OG0044.93± 2
OG0063.49± 65
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.10± 28
OG0010.12± 35
OG0030.12± 60
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.13± 49
OG0020.12± 68
OG0030.10± 46
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.12± 66
OG0020.10± 38
OG0030.17± 864
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.18± 11
OG0010.17± 10
OG0030.17± 10
OG0040.13± 9
OG0060.11± 13
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.02± 24
OG0010.02± 13
OG0030.02± 23
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.06± 17
OG0020.06± 16
OG0030.07± 18
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.06± 23
OG0020.05± 18
OG0030.04± 56
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00029.99± 9
OG00151.20± 13
OG00351.40± 16
OG00480.91± 6
OG00671.98± 14
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0001.64± 6
OG0013.51± 18
OG0033.77± 16
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0005.56± 8
OG00211.94± 20
OG00312.83± 19
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0005.03± 8
OG00210.48± 20
OG0039.77± 30
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0001.75± 30
OG0011.85± 111
OG0031.74± 75
OG0044.93± 2
OG0063.50± 64
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.06± 53
OG0010.07± 128
OG0030.07± 88
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.02± 68
OG0020.06± 89
OG0030.05± 176
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.06± 169
OG0020.07± 90
OG0030.11± 2318
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.52(0.50 to 0.60)
OG0011.00(1.00 to 1.00)
OG0031.02(1.00 to 1.02)
OG0042.02(2.02 to 2.02)
OG0062.07(2.02 to 2.23)
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.52(0.25 to 0.60)
OG0011.00(1.00 to 1.00)
OG0031.02(0.50 to 1.02)
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.52(0.25 to 0.60)
OG0021.00(1.00 to 1.00)
OG0031.02(1.00 to 1.02)
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.52(0.25 to 0.60)
OG0021.00(1.00 to 1.00)
OG0031.02(1.00 to 2.00)
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00024.00(24.00 to 24.00)
OG00124.05(24.00 to 24.30)
OG00324.00(24.00 to 24.00)
OG00424.00(24.00 to 24.00)
OG00624.00(24.00 to 24.10)
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00024.00(18.00 to 24.00)
OG00124.00(18.00 to 24.10)
OG00324.00(18.00 to 24.00)
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00018.00(18.00 to 24.00)
OG00224.00(18.00 to 24.00)
OG00324.00(18.00 to 24.00)
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00024.00(18.00 to 24.00)
OG00224.00(18.10 to 24.00)
OG00324.00(18.00 to 24.00)
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000719.86± 9
OG0011228.88± 14
OG0031233.66± 16
OG0041940.84± 6
OG0061726.43± 14
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00039.48± 6
OG00184.22± 18
OG00390.51± 16
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000133.35± 8
OG002286.34± 20
OG003308.35± 19
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000120.70± 8
OG002251.56± 20
OG003234.14± 30
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000719.86± 9
OG0011228.88± 14
OG0031233.66± 16
OG0041940.84± 6
OG0061726.43± 14
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00039.48± 6
OG00184.22± 18
OG00390.51± 16
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000133.35± 8
OG002286.34± 20
OG003308.35± 19
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000120.70± 8
OG002251.56± 20
OG003234.14± 30
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.72± 9
OG0010.61± 13
OG0030.62± 16
OG0040.65± 6
OG0060.58± 14
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.04± 6
OG0010.04± 18
OG0030.05± 16
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.13± 8
OG0020.14± 20
OG0030.15± 19
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.12± 8
OG0020.13± 20
OG0030.12± 30
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0003.91± 8
OG0013.64± 19
OG0033.67± 21
OG0044.14± 4
OG0063.86± 18
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0003.89± 19
OG0013.45± 19
OG0033.38± 19
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0002.32± 15
OG0022.64± 12
OG0032.47± 24
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0002.55± 11
OG0022.78± 15
OG0033.13± 55
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0001.39± 9
OG0011.63± 13
OG0031.62± 16
OG0041.55± 7
OG0061.74± 14
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00025.35± 6
OG00123.75± 18
OG00322.09± 16
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0007.50± 8
OG0026.98± 20
OG0036.49± 19
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0008.28± 8
OG0027.96± 20
OG0038.54± 30
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0006.86± 5
OG0016.73± 11
OG0036.51± 11
OG0047.17± 9
OG0067.58± 10
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000105.98± 14
OG00172.51± 16
OG00369.65± 13
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00018.04± 14
OG00216.57± 18
OG00313.88± 21
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00021.86± 10
OG00218.79± 14
OG00330.21± 197
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.97± 4
OG0010.97± 7
OG0030.88± 11
OG0040.89± 6
OG0060.84± 9
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.95± 4
OG0010.98± 4
OG0030.86± 18
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.94± 4
OG0020.94± 13
OG0030.96± 5
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.95± 5
OG0020.97± 13
OG0030.94± 26
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.99± 5
OG0010.98± 7
OG0030.89± 11
OG0040.91± 6
OG0060.85± 9
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.96± 4
OG0010.99± 3
OG0030.87± 18
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.94± 4
OG0020.94± 13
OG0030.96± 5
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.96± 5
OG0020.97± 13
OG0030.94± 26
OG005
6
OG0045
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.92± 17
OG0011.13± 14
OG0030.97± 7
OG0041.01± 8
OG0060.88± 8
Free ERT
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.93± 11
OG0011.12± 7
OG0030.86± 37
OG004
Total ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.92± 15
OG0020.96± 11
OG0030.98± 12
OG005
Free ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0000.90± 15
OG0020.98± 11
OG0030.85± 40
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000339.62(97.70 to 605.00)
OG001748.60(573.00 to 995.00)
OG003794.50(414.00 to 1620.00)
OG004768.60(451.00 to 1090.00)
OG006670.13(87.80 to 1630.00)
Unchanged ERT - 4-8 h
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000159.23(74.20 to 268.00)
OG001275.67(105.00 to 414.00)
OG003202.67(163.00 to 272.00)
OG004
Unchanged ERT - 8-12 h
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00064.30(19.80 to 83.80)
OG001122.38(58.80 to 204.00)
OG003128.93(77.50 to 202.00)
OG004
Unchanged ERT - 12-24 h
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00049.80(25.60 to 66.50)
OG00184.22(49.90 to 150.00)
OG00354.38(19.20 to 106.00)
OG004
Unchanged ZID - 0-4 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000544.83(259.00 to 816.00)
OG0021336.67(1060.00 to 1620.00)
OG0031475.00(1080.00 to 2040.00)
OG005
Unchanged ZID - 4-8 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000150.55(62.60 to 277.00)
OG002360.00(250.00 to 552.00)
OG003259.00(149.00 to 314.00)
OG005
Unchanged ZID - 8-12 h
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00033.28(6.88 to 51.30)
OG00280.35(56.90 to 162.00)
OG00383.72(38.20 to 123.00)
OG005
Unchanged ZID - 12-24 h
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0034
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00019.93(13.30 to 24.30)
OG00227.02(15.10 to 54.10)
OG00325.53(18.00 to 37.00)
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000594.00(204.00 to 856.00)
OG0011085.67(321.00 to 1490.00)
OG0031181.83(711.00 to 2190.00)
OG0041676.67(1200.00 to 2160.00)
OG0061572.17(843.00 to 2400.00)
Unchanged ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000733.17(370.00 to 922.00)
OG0021798.33(1470.00 to 1960.00)
OG0031836.67(1420.00 to 2420.00)
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00033.96(9.77 to 60.50)
OG00137.46(28.70 to 49.80)
OG00339.75(20.70 to 81.20)
OG00425.60(15.00 to 36.20)
OG00622.33(2.93 to 54.30)
Unchanged ERT- 4-8 h
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00015.92(7.42 to 26.80)
OG00113.78(5.27 to 20.70)
OG00310.14(8.14 to 13.60)
OG004
Unchanged ERT- 8-12 h
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0006.43(1.98 to 8.38)
OG0016.12(2.94 to 10.20)
OG0036.45(3.88 to 10.10)
OG004
Unchanged ERT- 12-24 h
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0004.98(2.56 to 6.65)
OG0014.21(2.49 to 7.48)
OG0032.72(0.96 to 5.32)
OG004
Unchanged ZID - 0-4 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00054.48(25.90 to 81.60)
OG00266.70(52.80 to 81.00)
OG00373.75(54.20 to 102.00)
OG005
Unchanged ZID - 4-8 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00015.06(6.26 to 27.70)
OG00217.98(12.50 to 27.60)
OG00312.96(7.45 to 15.70)
OG005
Unchanged ZID - 8-12 h
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0003.33(0.69 to 5.13)
OG0024.02(2.84 to 8.11)
OG0034.18(1.91 to 6.13)
OG005
Unchanged ZID - 12-24 h
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0034
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0001.99(1.33 to 2.43)
OG0021.35(0.76 to 2.70)
OG0031.27(0.90 to 1.85)
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00059.40(20.40 to 85.60)
OG00154.32(16.10 to 74.70)
OG00358.98(35.50 to 109.00)
OG00455.85(40.10 to 71.80)
OG00652.43(28.10 to 79.90)
Unchanged ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00073.32(37.00 to 92.20)
OG00289.82(73.30 to 97.90)
OG00391.75(70.90 to 121.00)
OG005
6
OG0046
OG0056
OG0066
6
ParticipantsOG0046
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.75± 61
OG0010.78± 57
OG0030.79± 41
OG0040.76± 19
OG0060.73± 42
Unchanged ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0004.98± 39
OG0025.88± 15
OG0035.63± 36
OG005
6
OG0045
OG0056
OG0066
5
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000357.83(208.00 to 525.00)
OG001702.30(39.50 to 1270.00)
OG003777.80(433.00 to 1490.00)
OG0041010.40(655.00 to 1530.00)
OG006998.17(467.00 to 1670.00)
Unchanged ERT - 4-8 h
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000113.37(10.10 to 205.00)
OG001344.17(132.00 to 911.00)
OG003234.94(97.70 to 473.00)
OG004
Unchanged ERT - 8-12 h
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00054.95(7.16 to 88.10)
OG001136.54(21.70 to 198.00)
OG00388.86(48.10 to 153.00)
OG004
Unchanged ERT - 12-24 h
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00043.04(26.70 to 68.20)
OG00129.69(9.35 to 72.20)
OG00365.46(55.00 to 81.10)
OG004
Unchanged ZID - 0-4 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000624.50(383.00 to 824.00)
OG0021210.33(691.00 to 1570.00)
OG0031465.00(1465.00 to 1640.00)
OG005
Unchanged ZID - 4-8 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000110.20(7.22 to 173.00)
OG002302.00(302.00 to 302.00)
OG003246.00(219.00 to 307.00)
OG005
Unchanged ZID - 8-12 h
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00027.93(3.55 to 45.10)
OG00245.58(23.10 to 55.40)
OG00362.98(40.20 to 93.60)
OG005
Unchanged ZID - 12-24 h
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00014.75(7.36 to 25.40)
OG00262.37(18.70 to 124.00)
OG00332.48(13.30 to 44.80)
OG005
6
OG0045
OG0056
OG0066
5
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG000552.83(325.00 to 778.00)
OG0011067.33(340.00 to 1700.00)
OG0031166(652.00 to 2200.00)
OG0041898.00(1060.00 to 3000.00)
OG0061624.50(887.00 to 2320.00)
Unchanged ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG000770.17(495.00 to 1030.00)
OG0021080.00(1080.00 to 1080.00)
OG0031808.33(1580.00 to 1970.00)
OG005
6
OG0045
OG0056
OG0066
5
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00035.78(20.80 to 52.50)
OG00135.09(1.97 to 63.30)
OG00338.94(21.70 to 74.60)
OG00433.68(21.80 to 51.00)
OG00633.28(15.60 to 55.80)
Unchanged ERT - 4-8 h
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00011.34(1.01 to 20.50)
OG00117.19(6.62 to 45.50)
OG00311.72(4.89 to 23.60)
OG004
Unchanged ERT - 8-12 h
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0005.50(0.72 to 8.81)
OG0016.83(1.08 to 9.91)
OG0034.45(2.41 to 7.67)
OG004
Unchanged ERT - 12-24 h
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0004.30(2.67 to 6.82)
OG0011.48(0.47 to 3.61)
OG0033.27(2.75 to 4.06)
OG004
Unchanged ZID - 0-4 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00062.45(38.30 to 82.40)
OG00260.40(34.50 to 78.40)
OG00373.27(62.60 to 82.10)
OG005
Unchanged ZID - 4-8 h
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00011.02(0.72 to 17.30)
OG00215.10(15.10 to 15.10)
OG00312.28(11.00 to 15.30)
OG005
Unchanged ZID - 8-12 h
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0002.79(0.36 to 4.51)
OG0022.28(1.16 to 2.77)
OG0033.15(2.01 to 4.68)
OG005
Unchanged ZID - 12-24 h
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0001.48(0.74 to 2.54)
OG0023.12(0.93 to 6.20)
OG0031.63(0.67 to 2.24)
OG005
6
OG0045
OG0056
OG0066
5
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG00055.28(32.50 to 77.80)
OG00153.35(17.00 to 84.90)
OG00358.36(32.60 to 110.00)
OG00463.28(35.50 to 100.00)
OG00654.20(29.60 to 77.40)
Unchanged ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG00077.02(49.50 to 103.00)
OG00253.80(53.80 to 53.80)
OG00390.35(78.80 to 98.50)
OG005
6
OG0045
OG0056
OG0066
5
ParticipantsOG0045
ParticipantsOG0050
ParticipantsOG0066
Title
Measurements
OG0000.74± 28
OG0010.78± 53
OG0030.84± 48
OG0040.92± 37
OG0060.9± 44
Unchanged ZID
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0036
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0066
Title
Measurements
OG0005.59± 35
OG0024.68± NACannot be calculated as data only available for one participant