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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002626-12 | EudraCT Number |
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To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06427878 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06427878 | Drug | Intravenous, 100 micrograms, single dose, 30 minute infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | |
| Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf) | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | |
| Maximum Observed Plasma Concentration (Cmax) | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | |
| Plasma Terminal Elimination Half Life (t1/2) | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | |
| Plasma Systemic Clearance (CL) | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | |
| Plasma Volume of Distribution at Steady State (Vss) | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5) | Day 1 Hr 0 to 12.5 | |
| Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%) | Day 1 Hr 0 to 12.5 |
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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 |
|---|---|---|---|---|---|---|
| Quotient Clinical Ltd | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| Renal clearance (CLr) | Day 1 Hr 0 to 12.5 |