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OpenTrials
Completed

NCT Number: NCT00909688

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

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

Completed

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BLI-489

Drug

Placebo

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 28, 2009
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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