Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
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.
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 17, 2009
July 1, 2009
2 months
May 6, 2009
July 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
10 days
Secondary Outcomes (1)
Safety as measured by the number of adverse events and serious adverse events.
10 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Presence of history of any disorder that may prevent the successful completion of the study.
- History of drug abuse within 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Philadelphia, Pennsylvania, 19148, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 7, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 17, 2009
Record last verified: 2009-07