Bacterial infections
Conditions
Sponsors
Wockhardt Bio AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, 18-65 years of age both inclusive 2. Have a body Mass Index (BMI) between 18 to 30 kg/m2 (both inclusive) calculated as weight (kg) / height (m2) 3. Medical history without any major pathology 4. Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40-100 beats per minute or higher, computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology and showing no clinically relevant deviations as judged by the Principal Investigator 5. Glomerular filtration rate (GFR) > 80 mL/min. 6. All values for blood and urine tests within the normal range or showing no clinically relevant deviations as judged by the Principal Investigator. Re-screening may be allowed only once. 7. Abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit or grapefruit (juice) from 48 hours prior to entry in the clinical research center (Day -1) until discharge 8. Females must be non-pregnant and not breast feeding (non-pregnancy will be confirmed by a serum pregnancy test conducted at screening and prior to any dosing period), or of no childbearing potential at screening. 9. In sexually active subjects, willingness to use 2 effective methods of contraception, of which one must be a physical barrier method (a condom, a diaphragm or cervical/vault cap), and other could be oral contraceptives, intra-uterine device or spermicidal jelly. Since a systemic or individual effect of WCK 4282 on the PK of oral contraceptives cannot not be ruled out, females on oral contraceptives will be informed of a possible effect and asked to continue their contraceptive daily between screening and the last follow-up (i.e., also continue with contraceptive during a possible planned stop week). 10. Males should not donate sperm until 90 days after the follow-up visit. 11. Willing to sign the Informed Consent Form and adhere to the study restrictions and assessment schedule.
Exclusion criteria
Exclusion criteria: 1. Receipt of WCK 4282 in the past. 2. History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 3. History of epilepsy 4. Active Candida infection 5. Cystic fibrosis 6. Mental handicap 7. History of relevant drug and/or food allergies particularly known hypersensitivity to cefepime or tazobactam, cephalosporins or penicillins. 8. Receipt of a prescription or non-prescription drug within 14 days prior entry into clinical research centre (Day -1) except for acetaminophen (paracetamol) which is allowed for up to 3 days prior entry into clinical research centre (Day -1). Multivitamins and vitamin C are allowed up to 7 days before entry into the clinical research centre (Day -1). 9. Smoking within 60 days prior to drug administration and through the follow-up visit. 10. History of alcohol abuse and/or drug addiction (including soft drugs like cannabis products) 11. Intake of more than 21 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 30 mL of spirits) 12. Participation in a drug study within 90 days prior study start. 13. Donation of blood (500 mL or more) within 90 days prior to study start (Day -1). 14. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) 15. Positive screen on hepatitis B surface antigen (HBsAg), anti hepatitis C virus (HCV) antibodies or anti human immunodeficiency virus (HIV) 1/2 antibodies 16. Illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Principal Investigator 17. Strenuous activity (e.g., sports) is not allowed from 96 hours (4 days) prior to entry into the clinical research center (Day -1) and throughout the study (until the final follow-up visit has been conducted)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability and pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed