Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.
Key facts
- Study ID
- NCT00909688
- Run by
- Wyeth is now a wholly owned subsidiary of Pfizer
- People needed
- 16
- Starts
- 2009-06-05
- Expected to finish
- 2009-07-24
- Last updated by the study team
- 2018-09-27
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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