Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

Study Overview
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Brief Summary
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• 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.

Official Title
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Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime Administered as Single IV Doses in Healthy Human Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: WCK 5107 250 mg to 2000 mg
* Drug: Cefepime 2000 mg
* Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18-55 years of age (both inclusive). Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2). Medical history without any major pathology/surgery in the last 6 months prior to screening. Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute. Calculated creatinine clearance ≥80 mL/min Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator. Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit. 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. 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: History/evidence of clinically relevant pathology. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs. A positive screen result for drugs of abuse/alcohol at admission to the study center. Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations. Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening. 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. History of blood donation of more than 500 mL in the last 2 months prior to screening. Current use or has used tobacco- or nicotine-containing products.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 5107<br>A single administration of the investigational product will be administered intravenously in 7 SAD cohorts at different dose level . The SAD cohorts will enroll 10 subjects ( 8 on active drug and 2 on placebo) | Drug: WCK 5107 250 mg to 2000 mg<br> <br> Drug: Placebo<br> <br> |
| Experimental: WCK 5107 1000 mg and Cefepime 2000 mg<br>In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments. | Drug: WCK 5107 250 mg to 2000 mg<br> <br> Drug: Cefepime 2000 mg<br> <br> Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination<br> <br> |
| Experimental: WCK 5107 2000 mg and Cefepime 2000 mg<br>In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments. | Drug: WCK 5107 250 mg to 2000 mg<br> <br> Drug: Cefepime 2000 mg<br> <br> Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - number of adverse events . | To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. | 14 days | 
| Tolerability-measure of laboratory parameters | To evaluate the tolerability of single intravenous doses of WCK | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK- Cmax | To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. | 3 days | 
| PK-AUC | To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. | 3 days | 
| PK-time to Cmax | To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects. | 3 days |