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The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04418948 30 mg | Experimental |
| |
| PF-04418948 100 mg | Experimental |
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| PF-04418948 300 mg | Experimental |
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| PF-04418948 1000 mg | Experimental |
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| PF-04418948 3000 mg | Experimental |
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| PF-04418948 4500 mg | Experimental |
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| PF-04418948 6000 mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04418948 | Drug | solution, 30 mg, single |
| |
| PF-04418948 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2 | 240 hours | |
| Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine). | 240 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level. | 48 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 | Brussels | 1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C570688 | 1-(4-fluorobenzoyl)-3-(((6-methoxy-2-naphthyl)oxy)methyl)azetidine-3-carboxylic acid |
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| Drug |
solution, 100 mg, single |
|
| PF-04418948 | Drug | solution, 300 mg, single |
|
| PF-04418948 | Drug | solution, 1000 mg, single |
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| PF-04418948 | Drug | solution, 3000 mg, single |
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| PF-04418948 | Drug | solution, 4500 mg, single |
|
| PF-04418948 | Drug | solution, 6000 mg, single |
|