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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:5/4/2016
Start Date:August 2015
End Date:December 2015

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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

• 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.


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.
We found this trial at
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Overland Park, Kansas 66211
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Overland Park, KS
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