Healthy
Conditions
Brief summary
• To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.
Interventions
DRUGWCK 5107 250 mg to 2000 mg
DRUGCefepime 2000 mg
DRUGWCK 5107 1000/2000 mg with Cefepime 2000 mg combination
DRUGPlacebo
Sponsors
Quintiles, Inc.
Wockhardt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, 18-55 years of age (both inclusive). 2. Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2). 3. Medical history without any major pathology/surgery in the last 6 months prior to screening. 4. Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute. 5. Calculated creatinine clearance ≥80 mL/min 6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator. 7. Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit. 8. Females should not be pregnant or breast feeding (pregnancy will be confirmed by a urine pregnancy test at screening with confirmation by a serum pregnancy test at admission) or of non-childbearing potential at screening. 9. Females must be either post-menopausal for at least 1 year, surgically sterile (bilateral oophorectomy or hysterectomy), or practicing 1 of the acceptable methods of birth control.
Exclusion criteria
1. History/evidence of clinically relevant pathology. 2. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs. 3. A positive screen result for drugs of abuse/alcohol at admission to the study center. 4. Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations. 5. Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening. 6. Any strenuous activity within 4 days prior to admission to the study center. Strenuous being defined as any hard labor or exercise outside of a subject's usual behavior. 7. History of blood donation of more than 500 mL in the last 2 months prior to screening. 8. Current use or has used tobacco- or nicotine-containing products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - number of adverse events . | 14 days | To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. |
| Tolerability-measure of laboratory parameters | 14 days | To evaluate the tolerability of single intravenous doses of WCK |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK- Cmax | 3 days | To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. |
| PK-AUC | 3 days | To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. |
| PK-time to Cmax | 3 days | To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. |
Countries
United States
Outcome results
None listed