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Completed

NCT Number: NCT00376324

Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Men and nonlactating and nonpregnant women greater than or equal to 18 years of age.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG).
  • Have a high probability for compliance with and completion of the study.

Exclusion:

  • Subjects with chronic osteomyelitis.
  • Subjects who have known or suspected hypersensitivity to tigecycline or other tetracyclines.
  • Involvement in other investigational studies of any type within 30 days before test article administration.

Treatment and study plan

tigecycline

Drug

Each subject will receive 3 IV doses of tigecycline, as 30-minute infusions: Dose 1 = 100 mgDose 2 = 50 mgDose 3 = 50 mg The doses of tigecycline will be administered to the subjects at approximately 12-hour intervals.

Primary outcomes

  1. To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2006
Registry last updated
Jul 10, 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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