Status:
COMPLETED
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.
Eligibility Criteria
Inclusion
- Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening;
- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.;
- Healthy as determined by the investigator on the basis of screening evaluations;
- Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula;
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay;
- Have a high probability for compliance with and completion of the study.
Exclusion
- Presence or history of any disorder that may prevent the successful completion of the study;
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
- Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product;
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1;
- History of drug abuse within 1 year before study day 1;
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
Key Trial Info
Start Date :
June 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00909688
Start Date
June 5 2009
End Date
July 24 2009
Last Update
September 27 2018
Active Locations (1)
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1
Tacoma, Washington, United States, 98418