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

NCT00909688

Last updated date
Study Location
Tacoma, Washington, 98418, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
Official Title  ICMJE Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects
Brief Summary To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BLI-489
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: 1
    BLI-489
    Intervention: Drug: BLI-489
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2009)
40
Actual Study Completion Date  ICMJE July 24, 2009
Actual Primary Completion Date July 24, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909688
Other Study ID Numbers  ICMJE 3219K1-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2018

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