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In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. The study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [11C]PF-06427878 | Experimental | Single intravenous infusion of [11C]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
|
| PF-06427878 10 mg | Experimental | Single oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
|
| PF-06427878 600 mg | Experimental | Single oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]PF-06427878 | Drug | Single administration via intravenous infusion of 20 ug [11C]PF-06427878 on Day 1 of all 3 Periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent injected radioactivity (per gram) over time in the liver | All Periods;Day 1;0-120min | |
| Percent injected radioactivity (per gram) over time in the plasma | All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min |
| Measure | Description | Time Frame |
|---|---|---|
| Relative radioactivity in liver versus plasma | Ratio of AUC of percent injected radioactivity (per gram) over time in liver to AUC of percent injected radioactivity (per gram) over time in plasma | All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min |
| Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable |
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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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States | ||
| Anylan Center |
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| PF-06427878 10 mg | Drug | Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration |
|
| PF-06427878 600 mg | Drug | Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration |
|
| All Periods;Day 1;0-2hr |
| % of parent in plasma over time | Parent is study drug PF-06427878 | All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min |
| Plasma PK of PF-06427878: AUClast, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: AUClast, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the biliary tree, if this region is identifiable | All Periods;Day 1;0-2hr |
| Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the abdominal fat, if this region is identifiable | All Periods;Day 1;0-2hr |
| Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the kidney, if this region is identifiable | All Periods;Day 1;0-2hr |
| Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the urinary bladder, if this region is identifiable | All Periods;Day 1;0-2hr |
| Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the thigh muscle, if this region is identifiable | All Periods;Day 1;0-2hr |
| Plasma PK of PF-06427878: AUCinf, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: Cmax, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: Tmax, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: t½, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: CL, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: Vss, as data permit | Period 1;Day 1;0,3,5,15,30,60,90,120,135min |
| Plasma PK of PF-06427878: Vss, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| Plasma PK of PF-06427878: AUCinf, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| Plasma PK of PF-06427878: Cmax, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| Plasma PK of PF-06427878: Tmax, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| Plasma PK of PF-06427878: t½, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| Plasma PK of PF-06427878: CL/F, as data permit. | Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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