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Study Evaluating Single Doses of BLI-489 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820404
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : July 17, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
BLI-489
 Drug: BLI-489
Placebo Comparator: 2
Placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities. [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics as evaluated by drug concentrations in the blood and urine. [ Time Frame: 4 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men or women of nonchildbearing potential, 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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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): NCT00820404


Locations
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United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00820404    
Other Study ID Numbers: 3219K1-1000
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: July 17, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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BLI-489
beta-Lactamase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents