Clinical trial NCT01287793: Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.

Detailed description: evaluation of effect of tigecycline on QT/QTc in healthy volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy
* Body mass index 17.5 - 30.5 kg
* Total body weight greater than 50 kg

Exclusion Criteria:

* Recent history of diarrhea
* Use of oral antibiotics in the last 2 weeks
* History of risk factors for QT prolongation pregnant females
* Nursing females

Primary outcomes:
measure: Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses
timeFrame: Up to 96 hours
Secondary outcomes:
measure: QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods
timeFrame: -2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Maximum concentration pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Time of maximum concentration pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Elimination rate constant pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Half life pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Clearance pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
measure: Response-exposure relationships between QT/QTc and tigecycline concentration
timeFrame: -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.