Tacoma, Washington, 98418, United States
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
DrugPlacebo
DrugPrimary outcomes
-
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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