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Study Evaluating BLI-489 and Piperacillin in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00894439
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : July 17, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: BLI-489/Piperacillin Drug: BLI-489 Drug: Piperacillin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: BLI-489/Piperacillin Drug: BLI-489 Drug: Piperacillin



Primary Outcome Measures :
  1. Pharmacokinetics as evaluated by drug concentrations in the blood and urine. [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Safety as measured by the number of adverse events and serious adverse events. [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening.
  2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
  3. Healthy as determined by the investigator on the basis of the screening evaluations.
  4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

  1. Presence of history of any disorder that may prevent the successful completion of the study.
  2. History of drug abuse within 1 year.

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): NCT00894439


Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00894439     History of Changes
Other Study ID Numbers: 3219K1-1002
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: July 17, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Piperacillin
BLI-489
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action