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Completed

NCT Number: NCT00854009

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

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.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, 1710014, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men, aged 20 to 50 years of age inclusive at screening.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.
  • Healthy as determined by the investigator on the basis of the screening evaluations.
  • Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion criteria

  • Presence of history of any disorder that may prevent the successful completion of the study.
  • History of drug abuse within 1 year.

Treatment and study plan

BLI-489

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Pharmacokinetics as evaluated by drug concentrations in the blood and urine.

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 2, 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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