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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: WCK 5107 250 mg to 2000 mg; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Quintiles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WCK 5107; 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: Placebo; Drug: WCK 5107 250 mg to 2000 mg
Experimental: WCK 5107 1000 mg and Cefepime 2000 mg; 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; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination
Experimental: WCK 5107 2000 mg and Cefepime 2000 mg; 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; Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimate): August 25, 2015

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefepime
• Other Study ID Numbers: W-5107-101