Philadelphia, Pennsylvania, 19148, United States
NCT Number: NCT00894439
Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
BLI-489/Piperacillin
DrugBLI-489
DrugPiperacillin
DrugPrimary 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.
Time frame: 10 weeks
Sponsors and collaborators
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Industry
Registry information
Official study 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.
Important dates
- Study start
- 2009
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- May 7, 2009
- Registry last updated
- Jul 17, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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