NCT00376324

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

2.1 years

First QC Date

September 12, 2006

Last Update Submit

July 8, 2009

Conditions

Healthy Subjects

Keywords

pharmacokineticshuman bone

Outcome Measures

Primary Outcomes (1)

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

    1 day

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

Related Publications (1)

  • Bhattacharya I, Gotfried MH, Ji AJ, Saunders JP, Gourley I, Diehl A, Korth-Bradley JM. Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures. J Clin Pharmacol. 2014 Jan;54(1):70-4. doi: 10.1002/jcph.201. Epub 2013 Oct 24.

    PMID: 24155157DERIVED

MeSH Terms

Interventions

Tigecycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 14, 2006

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

US(1)