Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: tigecycline
* Drug: tigecycline
* Drug: moxifloxacin
* Drug: 100 mL 0.9% Sodium Chloride intravenous
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose tigecycline<br> | Drug: tigecycline<br>* intravenous, 200 mg, single dose<br>* Other names: Tygacil, GAR-936;|
| Experimental: regular dose tigecycline<br> | Drug: tigecycline<br>* intravenous, 50 mg, single dose<br>* Other names: Tygacil, GAR-936;|
| Active Comparator: moxifloxacin<br> | Drug: moxifloxacin<br>* oral tablet, 400 mg, single dose<br>Drug: 100 mL 0.9% Sodium Chloride intravenous<br>* intravenous fluid, 100 mL, single dose<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 0.9% Sodium Chloride intravenous 100mL, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses |  | Up to 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline |  | -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours | 
| Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline |  | -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours | 
| Clearance pharmacokinetic endpoint for tigecycline |  | -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours | 
| Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline |  | -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours | 
| Response-exposure relationships between QT/QTc and tigecycline concentration |  | -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours |