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See termination reason in detailed description.
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The purpose of this study is to evaluate safety and tolerability after a single administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and biological activity.
Evaluate the safety, tolerability, plasma concentrations of PF-03382792 and other biological activity following a single dose of PF-03382792. Three ascending single doses of PF-03382792 were administered in this study (0.05 mg, 0.15mg and 0.5 mg). The decision to terminate the study was made on June 4, 2010 due to safety findings and limitations regarding the levels of the metabolite projected for doses above 0.5 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PART A: Ascending Cohorts | Experimental | Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg) |
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| PART B: Food effect | Experimental | Food effect on PF-03382792 PK |
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| PART C: CSF Cohort | Experimental | Optional CSF Cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03382792 Cohort 1 | Drug | First cohort for: Single oral ascending dose of PF-03382792, formulated in solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include evaluation: adverse events, change from baseline in vital signs, triplicate ECG (Part A only), singlet ECG for Parts B and C. 8 hours of cardiac telemetry postdose (Part A only). | For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days | |
| Additional Safety endpoints: clinical safety laboratory endpoints, plasma cortisol and ACTH, clinical examinations, slit lamp examination. | For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days | |
| Pharmacokinetic endpoints: plasma concentration of PF 03382792 over time (eg, AUC, Cmax, Tmax, t1/2), plasma concentration of PF 03227077 over time (eg, AUC, Cmax, Tmax, t1/2). | up to 72 hours post the final dose for each cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma aldosterone concentrations. | For Part A and C; up to 24 hours post final dose | |
| Change and percent change from baseline in average CSF sAPP fragment concentrations over all postdose collection time points up to 8 hours. • CSF sAPP fragment concentrations over time. • CSF concentration of PF 03382792 and PF |
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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-03382792 Cohort 2 | Drug | Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution. |
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| PF-03382792 | Drug | Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution. |
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| Food Effect cohort | Drug | Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion. |
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| CSF cohort | Drug | Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion. |
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| Part C only, up to 8 hours post dose |
| 03227077 over time (eg, AUC, Cmax, Tmax). | Part C only, up to 8 hours post dose |