Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
July 16, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Randomized, Open-label, Single-dose, 3-period Crossover Study to Describe the Pharmacokinetic Parameters of BLI-489 and Piperacillin When Administered Simultaneously Compared to When Each is Administered Alone.
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19148
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening.
- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
- Healthy as determined by the investigator on the basis of the screening evaluations.
- Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.
Exclusion Criteria:
- Presence of history of any disorder that may prevent the successful completion of the study.
- History of drug abuse within 1 year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
Time Frame: 10 days
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety as measured by the number of adverse events and serious adverse events.
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
May 6, 2009
First Submitted That Met QC Criteria
May 6, 2009
First Posted (Estimate)
May 7, 2009
Study Record Updates
Last Update Posted (Estimate)
July 17, 2009
Last Update Submitted That Met QC Criteria
July 16, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3219K1-1002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.