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Trial record 1 of 1 for:    NCT00894439
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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

Tracking Information
First Submitted Date  ICMJE May 6, 2009
First Posted Date  ICMJE May 7, 2009
Last Update Posted Date July 17, 2009
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2009)
Pharmacokinetics as evaluated by drug concentrations in the blood and urine. [ Time Frame: 10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2009)
Safety as measured by the number of adverse events and serious adverse events. [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
Official Title  ICMJE 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.
Brief Summary The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: BLI-489/Piperacillin
  • Drug: BLI-489
  • Drug: Piperacillin
Study Arms  ICMJE Experimental: 1
Interventions:
  • Drug: BLI-489/Piperacillin
  • Drug: BLI-489
  • Drug: Piperacillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00894439
Other Study ID Numbers  ICMJE 3219K1-1002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP