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The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single dose of PF-04991532 in healthy adult subjects with and without co-administration of cyclosporine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04991532 alone | Experimental |
| |
| PF-04991532 + cyclosporine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04991532 alone | Drug | a single dose of 150 mg PF-04991532, fasted |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time profile (AUC) | predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose | |
| Max observed plasma concentration (Cmax) | predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Cmax (Tmax) | predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose | |
| Terminal elimination half-life (t1/2) | predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose |
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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 | B-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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| ID | Term |
|---|---|
| C571532 | 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| PF-04991532 + cyclosporine |
| Drug |
a single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted |
|
| Total amount of unchanged drug excreted in the urine over 24 hours (Ae24) | 0-8, and 8-24hr postdose |
| Renal clearance (CLR) | 0-24hr |
| Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24(% excreted)) | 0-24hr |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |