Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Tigecycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00376324

3074A1-119

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)