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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.
evaluation of effect of tigecycline on QT/QTc in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose tigecycline | Experimental |
| |
| regular dose tigecycline | Experimental |
| |
| moxifloxacin | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tigecycline | Drug | intravenous, 200 mg, single dose |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23403419 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| tigecycline | Drug | intravenous, 50 mg, single dose |
|
|
| moxifloxacin | Drug | oral tablet, 400 mg, single dose |
|
| 100 mL 0.9% Sodium Chloride intravenous | Drug | intravenous fluid, 100 mL, single dose |
|
| placebo | Drug | 0.9% Sodium Chloride intravenous 100mL, single dose |
|
| 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |