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 |
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.
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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