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 |
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.
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.
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