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The purpose of this study is to evaluate the effect of itraconazole after multiple dose administration on the single dose PK of PF-06372865.
Study includes two treatment periods: period 1 is single dose of PF-06372865 given alone followed by at least 5-day washout out. The period 2 is 200 mg QD itraconazole given for 8 days with PF-06372865 single dose co-administered on day 4 (1 hour later than itraconazole dose). The PK and safety will be assessed and compared for single dose of PF-06372865 in period 1 and period 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06372865 treatment arm | Experimental | treatment arm includes two treatment periods, a single dose of PF-06372865 (period 1) followed by 8-days itraconazole with a single dose of PF-06372865 co-administered on Day 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06372865 | Drug | single dose of 7.5 mg PF-06372865 alone (period 1) or co-administered with itraconazole (period 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax ratio of PF-06372865 alone vs coadministration with itraconazole | The ratio of maximum plasma concentration of PF-06372865 following single dose co-administered with itraconazole vs given alone | 0 to 120 hours post PF-06372865 |
| AUC ratio of PF-06372865 alone vs coadministration with itraconazole | The ratio of AUC (area under plasma concentration curve) of PF-06372865 following single dose co-administered with itraconazole vs given alone | 0 to 120 hours post PF-06372865 |
| PF-06372865 Tmax | Time to PF-06372865 maximum concentration following single dose co-administered with itraconazole or given alone | 0 to 120 hours post PF-06372865 |
| T1/2 of PF-06372865 alone vs coadministration with itraconazole | T1/2 (half-life) of PF-06372865 following single dose co-administered with itraconazole or given alone | 0 to 120 hours post PF-06372865 |
| CL/F of PF-06372865 alone vs coadministration with itraconazole | CL/F (oral clearance) of PF-06372865 following single dose co-administered with itraconazole or given alone | 0 to 120 hours post PF-06372865 |
| Vz/F of PF-06372865 alone vs coadministration with itraconazole | Vz/F (volume distribution) of PF-06372865 following single dose co-administered with itraconazole or given alone | 0 to 120 hours post PF-06372865 |
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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 New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States | ||
| CRU New Haven |
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| itraconazole | Drug | Interacting drug which will be given 200 mg QD for 8 days in period 2 |
|
| New Haven |
| Connecticut |
| United States |
| ID | Term |
|---|---|
| C000630159 | PF-06372865 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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