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Completed

NCT Number: NCT00820404

Study Evaluating Single Doses of BLI-489 in 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.

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Key information

Conditions

Healthy Subjects

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Philadelphia, Pennsylvania, 19148, 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 nonchildbearing potential, 18 to 50 years of age inclusive at screening.
  • Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 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 Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2009
Registry last updated
Jul 17, 2009

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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