Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: BLI-489/Piperacillin (Drug); BLI-489 (Drug); Piperacillin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Summary
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given
together to healthy subjects.
Clinical Details
Official 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.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
Secondary outcome: Safety as measured by the number of adverse events and serious adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Philadelphia, Pennsylvania 19148, United States
Additional Information
Starting date: May 2009
Last updated: July 16, 2009
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