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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00909688
First received: May 27, 2009
Last updated: October 7, 2009
Last verified: October 2009
History of Changes

May 27, 2009
October 7, 2009
June 2009
October 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00909688 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy
  • Drug: BLI-489
  • Drug: placebo
  • Experimental: 1
    BLI-489
    Intervention: Drug: BLI-489
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909688
3219K1-1001
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP