Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00376324

Purpose

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

Condition	Intervention	Phase
Healthy Subjects	Drug: Tigecycline	Phase I

Drug Information available for: Tigecycline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone

Further study details as provided by Wyeth:

Primary Outcome Measures:

To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	September 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376324

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Arizona
	Recruiting
Phoenix, Arizona, United States, 85006

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-119
Study First Received:	September 12, 2006
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00376324
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

pharmacokinetics
human bone

Study placed in the following topic categories:

Tigecycline
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009