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

Wyeth

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BLI-489

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

3219K1-1001

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.