Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
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Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results. [ Time Frame: 4 months ]
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Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.