Study Evaluating Single Doses of BLI-489 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00820404
First received: January 9, 2009
Last updated: July 16, 2009
Last verified: July 2009

January 9, 2009
July 16, 2009
January 2009
April 2009   (final data collection date for primary outcome measure)
Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00820404 on ClinicalTrials.gov Archive Site
Pharmacokinetics as evaluated by drug concentrations in the blood and urine. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Evaluating Single Doses of BLI-489 in Healthy Subjects
Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy Subjects
  • 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.
 
Completed
54
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening.
  2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
  3. Healthy as determined by the investigator on the basis of the screening evaluations.
  4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

  1. Presence of history of any disorder that may prevent the successful completion of the study.
  2. History of drug abuse within 1 year.
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00820404
3219K1-1000
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
July 2009

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