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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Tacoma, Washington, 98418 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00909688
Pfizer
Terminated
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses

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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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00909688
3219K1-1001
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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