MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults

Healthy Subjects Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous Zidebactam in Healthy Adult Human Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674347
• Other study ID #: W-5107-102
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2016
• Last updated: August 3, 2016
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Wockhardt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.

Description:

A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts.

Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects.

Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Have a body mass index of 18 to 30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).

2. Medical history without any major pathology/surgery in the last 6 months prior to screening.

3. All values of hematology, serum chemistry, coagulation, and urinalysis showing no clinically significant deviations from normal as judged by the Principal Investigator.

4. Resting supine blood pressure of 90 to 139 (systolic)/40 to 89 (diastolic) mmHg and a resting pulse rate of 40 to 100 beats per minute.

5. Calculated creatinine clearance =80 mL/min (Cockcroft-Gault method).

6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.

Exclusion Criteria:

1. History of clinically significant food or drug allergy, including known hypersensitivity to ß lactam drugs or other related drugs.

2. History of Clostridium difficile induced diarrhea or infection within 1 year before screening

3. Consumed more than 28 units of alcohol per week at any time in the 6 months before investigational product administration

4. History/evidence of clinically relevant pathology related to the cardiovascular system, central nervous system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology or any other systemic disorder/major surgeries, that in the opinion of the Principal Investigator would confound the subject's participation and follow-up in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• 3 g or 6 g Zidebactam
IV for over a duration of 60 minutes
• Placebo
IV matching the Investigational drug

Locations

Country	Name	City	State
United States	Quintiles	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Wockhardt	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings.		14 days	Yes
Primary	Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results		14 days	Yes
Secondary	Pharmacokinetic parameters -maximum plasma concentration will be evaluated.		7 days	No
Secondary	Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated.		7 days	No
Secondary	Pharmacokinetic parameters- terminal half life etc will be evaluated		7 days	No