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The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04531083 or Placebo | Drug | Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index | days 1-15 | |
| Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests) | days 1-15 |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics of alternative formulations | days 1-15 |
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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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| PF-04531083 or Placebo | Drug | Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days. |
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| PF-04531083 or Placebo | Drug | Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days. |
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| PF-04531083 or Placebo | Drug | A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects. |
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