Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Wyeth is now a wholly owned subsidiary of Pfizer36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

TigecyclineDRUG

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 1 day

Data from ClinicalTrials.gov

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