Healthy Subjects (HS)
Conditions
Keywords
zidebactam
Brief summary
A Phase 1, Open-label Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion in Healthy Male Subjects
Detailed description
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
Interventions
DRUGzidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour
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).
Sponsors
Wockhardt
Covance
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index between 18.5 and 29.9 kg/m2, inclusive at Screening and Check-in (Day -1). * In good health, determined by no clinically significant findings from medical history, physical examination (at Check-in \[Day -1\]), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee). * Blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic, unless deemed not clinically significant by the Investigator (or designee). * History of a minimum of 1 bowel movement per day.
Exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder. * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. * History of alcoholism or drug/chemical abuse within 1 year prior to Check-in (Day -1). * Alcohol consumption of \>28 units per week for males. One unit of alcohol equals 12 oz. (360 mL) of beer, 1½ oz. (45 mL) of liquor, or 5 oz. (150 mL) of wine. * Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 14 days prior to Check-in. * Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount Excreted in Urine (Aeu) | 7 days | The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the amount excreted in urine (Aeu). |
| Cumulative Aeu in urine (Cum Aeu) | 7 days | The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative Aeu (Cum Aeu). |
| Percentage excreted in urine (feu): | 7 days | The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the percentage excreted in urine (feu). |
| Cumulative feu in urine(Cum feu): | 7 days | The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the cumulative feu (Cum feu). |
| Renal clearance (zidebactam only; CLR): | 7 days | The primary PK outcome endpoints of zidebactam and total radioactivity derived from urine collections is the renal clearance (zidebactam only; CLR). |
| Amount excreted in feces (Aef): | 7 days | The primary PK outcome endpoints of total radioactivity derived from fecal collections were the amount excreted in feces (Aef). |
| Cumulative Aef in feces (Cum Aef): | 7 days | The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative Aef (Cum Aef). |
| Percentage excreted in feces (fef): | 7 days | The primary PK outcome endpoints of total radioactivity derived from fecal collections were the percentage excreted in feces (fef). |
| Cumulative fef in feces (Cum fef): | 7 days | The primary PK outcome endpoints of total radioactivity derived from fecal collections were the cumulative fef (Cum fef). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Profile of [14C]-zidebactam | 7 days | The secondary metabolite endpoints is the metabolic profile of \[14C\]-zidebactam |
| Identification of [14C]-zidebactam metabolites | 7 days | The identification of \[14C\]-zidebactam metabolites is a secondary metabolite endpoint. |
| Incidence and severity of AEs | 7 Days | The incidence and severity of adverse events (AEs) is a secondary safety outcome measure. |
| Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results | 7 days | The incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results, is a secondary safety outcome measure. |
| 12-lead electrocardiogram (ECG) parameters | 7 days | The assessment of 12-lead electrocardiogram ECG QT Interval parameters is included as a secondary safety outcome measure. |
| Vital Signs -Supine Blood Pressure | 7 days | Supine Blood Pressure is a secondary outcome measure |
| Physical Examinations | 7 days | 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 |
| Vital Signs- supine pulse rate | 7 days | supine pulse rate is a secondary outcome measure |
| Vital Signs- respiratory rate | 7 Days | respiratory rate is a secondary outcome measure |
| Vital signs- oral body temperature | 7 days | oral body temperature is a secondary outcome measure |
Countries
United States
Outcome results
None listed