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The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.
The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single dose 3 period interleaved cross-over with placebo substitution |
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| Cohort 2 | Experimental | Single dose 4 period interleaved cross-over, placebo substitution, with food effect |
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| Cohort 3 | Experimental | Single dose 4 period cross-over, placebo insertion, with food effect |
|
| Optional Cohort 4 | Experimental | Single dose 3 period cross-over with placebo substitution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04995274 | Drug | Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints (AE's, Vital signs (supine & standing BP, PR), Triplicate ECG, 8 hours of cardiac telemetry postdose, Clinical safety laboratory endpoints, Digit Symbol Substitution Test (DSST), Drug Effect Questionnaire (DEQ), Clinical | up to 21 days post dose | |
| examinations) | up to 21 days post dose | |
| Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit. | up to 7 days post dose | |
| Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit. | up to 7 days post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma aldosterone concentrations | through 1 day post dosing |
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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-04995274 | Drug | Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg. |
|
| PF-04995274 | Drug | Planned single PO 120mg and 210mg doses of PF-04995274 |
|
| PF-04995274 | Drug | single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data |
|