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The study aims to determine what effect a high fat meal will have on the drug exposure of PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4) inhibitor on drug exposure of PF-04449913.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental |
| |
| Sequence 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04449913, ketoconazole | Drug | Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 8 days | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 8 days | |
| Apparent Oral Clearance (CL/F) | 8 days | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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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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| ID | Term |
|---|---|
| C000592580 | glasdegib |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| PF-04449913, ketoconazole | Drug | Subjects receive a 200 mg oral dose of PF-04449913 under fed conditions with washout, then single 200 mg oral dose of PF-04449913 under fasted with washout and finally a single 200 mg dose of PF-04449913 following dosing to steady state with ketoconazole |
|
| 8 days |
| Apparent Volume of Distribution (Vz/F) | 8 days |
| Plasma Decay Half-Life (t1/2) | 8 days |