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Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects

This study has been terminated.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: February 13, 2009
Last updated: October 7, 2009
Last verified: October 2009
The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated.

Condition Intervention Phase
Drug: BLI-489
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Japanese Male Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Pharmacokinetics as evaluated by drug concentrations in the blood and urine. [ Time Frame: 4 days ]

Estimated Enrollment: 56
Study Start Date: February 2009
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: BLI-489
Placebo Comparator: 2
Drug: Placebo


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Men, aged 20 to 50 years of age inclusive at screening.
  2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 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.
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Please refer to this study by its identifier: NCT00854009

Tokyo, Japan, 1710014
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00854009     History of Changes
Other Study ID Numbers: 3219K1-1004
Study First Received: February 13, 2009
Last Updated: October 7, 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy Subjects

Additional relevant MeSH terms:
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 24, 2017