Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

July 8, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Open-Label, Multiple-Dose Study of 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.

Study Overview

Status

Completed

Conditions

Healthy Subjects

Intervention / Treatment

Drug: Tigecycline

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Phoenix, Arizona, United States, 85006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration. Time Frame: 1 day	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bhattacharya I, Gotfried MH, Ji AJ, Saunders JP, Gourley I, Diehl A, Korth-Bradley JM. Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures. J Clin Pharmacol. 2014 Jan;54(1):70-4. doi: 10.1002/jcph.201. Epub 2013 Oct 24.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 12, 2006

First Submitted That Met QC Criteria