NCT00894439CompletedPhase 1
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.
Wyeth is now a wholly owned subsidiary of Pfizer0 sites24 target enrollmentStarted: May 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Primary Endpoint
- Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
Study Overview
Brief Summary
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Presence of history of any disorder that may prevent the successful completion of the study.
- •History of drug abuse within 1 year.
Arms & Interventions
1
Experimental
Intervention: BLI-489/Piperacillin (Drug)
1
Experimental
Intervention: BLI-489 (Drug)
1
Experimental
Intervention: Piperacillin (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
Time Frame: 10 days
Secondary Outcomes
- Safety as measured by the number of adverse events and serious adverse events.(10 weeks)
Investigators
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