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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

• 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.

Key facts

Study ID

NCT02532140

Run by

Wockhardt

People needed

88

Starts

2015-08-01

Expected to finish

2015-12-01

Last updated by the study team

2016-05-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Quintiles — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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