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To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of PF-03882845 in Healthy Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Healthy volunteers - PF-03882845 versus Placebo |
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| Cohort 2 | Experimental | Healthy volunteers - PF-03882845 versus Placebo |
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| Cohort 3 | Experimental | Healthy volunteers - PF-03882845 versus Placebo |
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| Cohort 4 | Experimental | Healthy volunteers - PF-03882845 versus Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03882845 or Placebo | Drug | PF-03882845 20 mg or Placebo, daily for 10 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Single-Dose PK for PF-03382845: Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd) | 13 days | |
| Safety and tolerability of PF-03382845 as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, electrocardiograms (ECGs) and potential sex hormone mediators. | 13 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the effect curve (AUEC) for serum aldosterone and PRA on Day 0 and on Days 1 and 10 after administration of PF-03882845 | 11 days | |
| Change from baseline(Day 0) to Day8 in exploratory mRNA gene expression biomarkers (SGK1:Sodium-and Serum/glucocorticoid regulated kinase 1 gene,ENaCα:Epithelial Sodium Channel alpha subunit,ENaCγ:Epithelial Sodium Channel gamma |
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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 | South Miami | Florida | 33143 | United States |
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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-03882845 or Placebo |
| Drug |
PF-03882845 60 mg or Placebo, daily for 10 days. |
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| PF-03882845 or Placebo | Drug | PF-03882845 120 mg or Placebo, daily for 10 days. |
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| PF-03882845 or Placebo | Drug | PF-03882845 185 mg or Placebo, daily for 10 days. |
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| 9 days |
| subunit,MR: Mineral corticoid Receptor,ACTβ:Beta Actin) after administration of PF-03882845 or placebo.These results will not be included in the study report | 9 days |
| ID | Term |
|---|---|
| C552104 | (3S,3aR)-2-(3-chloro-4-cyanophenyl)-3-cyclopentyl-3,3a,4,5-tetrahydro-2H-benzo(g)indazole-7-carboxylic acid |
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