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

Wockhardt

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Cefepime 2000 mg; Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination; Drug: Placebo; Drug: WCK 5107 250 mg to 2000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02532140

W-5107-101

Details and patient eligibility

About

• 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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88 participants in 3 patient groups

WCK 5107

Experimental group

Description:

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)

Treatment:

Drug: WCK 5107 250 mg to 2000 mg

Drug: Placebo

WCK 5107 1000 mg and Cefepime 2000 mg

Experimental group

Description:

In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.

Treatment:

Drug: WCK 5107 250 mg to 2000 mg

Drug: Cefepime 2000 mg

Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination

WCK 5107 2000 mg and Cefepime 2000 mg

Experimental group

Description:

In the crossover cohorts (WCK 5107 and cefepime, both alone and in combination), 9 subjects will receive all 3 treatments.

Treatment:

Drug: WCK 5107 250 mg to 2000 mg

Drug: Cefepime 2000 mg

Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination