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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909688
Recruitment Status : Terminated
First Posted : May 28, 2009
Last Update Posted : October 8, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: BLI-489 Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects
Study Start Date : June 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: 1
Drug: BLI-489
Placebo Comparator: 2
Drug: placebo

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909688

United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00909688     History of Changes
Other Study ID Numbers: 3219K1-1001
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy Subjects

Additional relevant MeSH terms:
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents