Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes