Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00376324
First received: September 12, 2006
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: Tigecycline
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tigecycline
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376324

Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00376324     History of Changes
Other Study ID Numbers: 3074A1-119
Study First Received: September 12, 2006
Last Updated: July 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
pharmacokinetics
human bone

Additional relevant MeSH terms:
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014