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Study Evaluating BLI-489 and Piperacillin in Healthy Subjects

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: May 6, 2009
Last updated: July 16, 2009
Last verified: July 2009
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.

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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

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

Enrollment: 24
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BLI-489/Piperacillin Drug: BLI-489 Drug: Piperacillin


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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00894439

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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00894439     History of Changes
Other Study ID Numbers: 3219K1-1002
Study First Received: May 6, 2009
Last Updated: July 16, 2009

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017