Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Randomized, 4-Way, Crossover Single Dose, Placebo And Active Controlled Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
1 other identifier
interventional
48
1 country
1
Brief Summary
Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2011
1 active site
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedMay 24, 2011
May 1, 2011
4 months
January 21, 2011
May 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
Up to 96 hours
Secondary Outcomes (10)
QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods
-2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Maximum concentration pharmacokinetic endpoint for tigecycline
-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Time of maximum concentration pharmacokinetic endpoint for tigecycline
-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Elimination rate constant pharmacokinetic endpoint for tigecycline
-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Half life pharmacokinetic endpoint for tigecycline
-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
- +5 more secondary outcomes
Study Arms (4)
high dose tigecycline
EXPERIMENTALregular dose tigecycline
EXPERIMENTALmoxifloxacin
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy
- Body mass index 17.5 - 30.5 kg
- Total body weight greater than 50 kg
You may not qualify if:
- Recent history of diarrhea
- Use of oral antibiotics in the last 2 weeks
- History of risk factors for QT prolongation pregnant females
- Nursing females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Publications (1)
Korth-Bradley JM, McGovern PC, Salageanu J, Matschke K, Plotka A, Pawlak S. Tigecycline does not prolong corrected QT intervals in healthy subjects. Antimicrob Agents Chemother. 2013 Apr;57(4):1895-901. doi: 10.1128/AAC.01576-12. Epub 2013 Feb 12.
PMID: 23403419DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 21, 2011
First Posted
February 1, 2011
Study Start
January 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 24, 2011
Record last verified: 2011-05