Healthy Subjects
Conditions
Keywords
pharmacokinetics, human bone
Brief summary
Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.
Interventions
DRUGTigecycline
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.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration. | 1 day |
Countries
United States
Outcome results
None listed