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This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.
To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing | Experimental | Ascending Doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03382792 0.5mg | Drug | 0.5 mg PF-03382792, qd, for 14 days or placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints include: AEs, vital signs, triplicate ECGs, | Day 0 to Day 28 | |
| Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations | Day 0 to Day 28 | |
| Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive), | Day 0 to Day 28 | |
| Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14. | Day 0 to Day 28 | |
| Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated. | Day 0 to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| PF-03382792 1.5 mg |
| Drug |
1.5 mg PF-03382792, qd, for 14 days or placebo |
|
| PF-03382792 5 mg | Drug | 5 mg PF-03382792, qd, for 14 days or placebo |
|
| PF-03382792 15 mg | Drug | 15 mg PF-03382792, qd, for 14 days or placebo |
|