Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:9/29/2018
Start Date:June 5, 2009
End Date:July 24, 2009

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Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

To determine the safety, tolerability, and drug absorption profile of multiple IV doses of
BLI 489 in healthy subjects.


Inclusion Criteria:

- 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 Criteria:

- 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.
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