A Phase 1, Open-label Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects
The primary objectives of the study are: * To determine mass balance and routes of elimination of \[zidebactam following administration of a single 1g (approximately 200 μCi) radiolabeled intravenous (IV) infusion of zidebactam in healthy male subjects * To assess the pharmacokinetics (PK) of a single IV infusion of zidebactam * To determine the whole blood and plasma concentrations of total radioactivity following a single IV infusion of -zidebactam * To determine the urinary and fecal recovery of the total administered radioactive dose The secondary objectives of the study are: * To characterize and identify metabolites of zidebactam in plasma, urine, and feces, as applicable * To determine plasma and urine concentrations of non-radiolabeled zidebactam * To assess the safety and tolerability of zidebactam
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour following at least an 8-hour fast from food (not including water).
Covance Clinical Research Unit Inc. 3402 Kinsman Boulevard Madison, Wisconsin 53704 USA
Madison, Wisconsin, United States
Amount Excreted in Urine (Aeu)
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the amount excreted in urine (Aeu).
Time frame: 7 days
Cumulative Aeu in urine (Cum Aeu)
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative Aeu (Cum Aeu).
Time frame: 7 days
Percentage excreted in urine (feu):
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the percentage excreted in urine (feu).
Time frame: 7 days
Cumulative feu in urine(Cum feu):
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative feu (Cum feu).
Time frame: 7 days
Renal clearance (zidebactam only; CLR):
The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the renal clearance (zidebactam only; CLR).
Time frame: 7 days
Amount excreted in feces (Aef):
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the amount excreted in feces (Aef).
Time frame: 7 days
Cumulative Aef in feces (Cum Aef):
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative Aef (Cum Aef).
Time frame: 7 days
Percentage excreted in feces (fef):
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The primary PK outcome endpoints of total radioactivity derived from fecal collections were the percentage excreted in feces (fef).
Time frame: 7 days
Cumulative fef in feces (Cum fef):
The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative fef (Cum fef).
Time frame: 7 days
Metabolic Profile of [14C]-zidebactam
The secondary metabolite endpoints is the metabolic profile of \[14C\]-zidebactam
Time frame: 7 days
Identification of [14C]-zidebactam metabolites
The identification of \[14C\]-zidebactam metabolites is a secondary metabolite endpoint.
Time frame: 7 days
Incidence and severity of AEs
The incidence and severity of adverse events (AEs) is a secondary safety outcome measure.
Time frame: 7 Days
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results
The incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results, is a secondary safety outcome measure.
Time frame: 7 days
12-lead electrocardiogram (ECG) parameters
The assessment of 12-lead electrocardiogram ECG QT Interval parameters is included as a secondary safety outcome measure.
Time frame: 7 days
Vital Signs -Supine Blood Pressure
Supine Blood Pressure is a secondary outcome measure
Time frame: 7 days
Physical Examinations
Physical examinations is a secondary safety outcome measure. To assess the outcome measure a questionnaire includes below mentioned measurements. General Appearance Skin Lymph Nodes HEENT Neck Thorax/Lungs Cardiovascular Abdomen Musculoskeletal Neurological
Time frame: 7 days
Vital Signs- supine pulse rate
supine pulse rate is a secondary outcome measure
Time frame: 7 days
Vital Signs- respiratory rate
respiratory rate is a secondary outcome measure
Time frame: 7 Days
Vital signs- oral body temperature
oral body temperature is a secondary outcome measure
Time frame: 7 days