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See termination reason in detailed description.
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To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.
The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Placebo Comparator | Cohort 1 completed. |
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| Cohort 2 | Placebo Comparator | Cohort 2 not studied |
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| Cohort 3 | Placebo Comparator | Cohort 3 not studied |
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| Cohort 4 | Placebo Comparator | Cohort 4 not studied |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF 03882845 and Placebo | Drug | The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Single Dose PK: Cmax, Tmax, and AUCtau; Multiple Dose PK (Assumed Steady State): 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 as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, and electrocardiograms (ECGs). | 13 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10. | 14 days |
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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 | New Haven | Connecticut | 06511 | 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 and Placebo | Drug | The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days. |
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| PF 03882845 and Placebo | Drug | The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days. |
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| PF 03882845 and Placebo | Drug | The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days. |
|