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

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ClinicalTrials.gov Identifier: NCT02532140
Recruitment Status : Completed
First Posted : August 25, 2015
Last Update Posted : May 3, 2016
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Wockhardt

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: WCK 5107 250 mg to 2000 mg Drug: Cefepime 2000 mg Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : August 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: WCK 5107 250 mg to 2000 mg
Drug: Placebo
Experimental: 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.
Drug: WCK 5107 250 mg to 2000 mg
Drug: Cefepime 2000 mg
Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination
Experimental: 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.
Drug: WCK 5107 250 mg to 2000 mg
Drug: Cefepime 2000 mg
Drug: WCK 5107 1000/2000 mg with Cefepime 2000 mg combination



Primary Outcome Measures :
  1. Safety - number of adverse events . [ Time Frame: 14 days ]
    To evaluate the safety of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

  2. Tolerability-measure of laboratory parameters [ Time Frame: 14 days ]
    To evaluate the tolerability of single intravenous doses of WCK


Secondary Outcome Measures :
  1. PK- Cmax [ Time Frame: 3 days ]
    To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

  2. PK-AUC [ Time Frame: 3 days ]
    To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

  3. PK-time to Cmax [ Time Frame: 3 days ]
    To evaluate the PK of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532140


Locations
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United States, Kansas
Quintiles
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Wockhardt
Quintiles, Inc.

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Responsible Party: Wockhardt
ClinicalTrials.gov Identifier: NCT02532140     History of Changes
Other Study ID Numbers: W-5107-101
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Cefepime
Anti-Bacterial Agents
Anti-Infective Agents