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

NCT ID: NCT02532140

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

WCK 5107 250 mg to 2000 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

WCK 5107 250 mg to 2000 mg

Intervention Type: DRUG

Cefepime 2000 mg

Intervention Type: DRUG

WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

WCK 5107 250 mg to 2000 mg

Intervention Type: DRUG

Cefepime 2000 mg

Intervention Type: DRUG

WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

Intervention Type: DRUG

Interventions

WCK 5107 250 mg to 2000 mg

Intervention Type: DRUG

Cefepime 2000 mg

Intervention Type: DRUG

WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Wockhardt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quintiles

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

W-5107-101

Identifier Type: -

Identifier Source: org_study_id