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
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
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014