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This study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.
To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Healthy Adult | Experimental | Ascending Doses in Healthy Adult Volunteers |
|
| Dosing Healthy Elderly | Experimental | Dosing in Healthy Elderly volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1 mg PF-04995274 | Drug | 0.1 mg PF-04995274, qd, for 14 days or placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST)) | Day 0 to Day 28 | |
| Pharmacokinetic endpoints Plasma concentration of PF 04995274 over time (eg, AUC, Cmax, Tmax, t1/2), Plasma concentration of PF 05082547 over time (eg, AUC, Cmax, Tmax, t1/2). | Day 0 to Day 28 | |
| Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects. | Day 0 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcomes |
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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 | Overland Park | Kansas | 66211 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 1 mg PF-04995274 |
| Drug |
1 mg PF-04995274, qd, for 14 days or placebo |
|
| 10 mg PF-04995274 | Drug | 10 mg PF-04995274, qd, for 14 days or placebo |
|
| 15 mg PF-04995274 | Drug | 15 mg PF-04995274, qd, for 14 days or placebo |
|
| 1.0 mg PF-04995274 | Drug | 1.0 mg PF-04995274, qd, for 14 days or placebo |
|
| 15 mg PF-04995274 | Drug | 15 mg PF-04995274, qd, for 14 days or placebo |
|
| Overland Park |
| Kansas |
| 66212 |
| United States |