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The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] PF-04449913 | Drug | Single oral dose of 100 mg PF-04449913 + 100µCi of [14C] PF-04449913 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 7 days |
| Maximum Observed Plasma Concentration (Cmax) | 7 days | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] for total radioactivity related to drug product | AUC (0 - 8)= Area under the plasma radioactivity concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 7 days |
| Maximum Observed Plasma Concentration (Cmax) for total radioactivity related to drug product | 7 days | |
| Cumulative recovery of radioactivity in excreta | Total percentage of dosed radioactivity recovered in urine and feces | 7 days |
| Radioactivity in blood | Total percentage of radioactivity in blood related to drug product | 7 days |
| Urine PF-04449913 PK parameters | Measure of renal clearance (CLr), amount excreted unchanged in urine (Ae) and the fraction of dose excreted unchanged in urine (AE%) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 7 days |
| Plasma Decay Half-Life (t1/2) |
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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 | Madison | Wisconsin | 53704 | 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 |
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| 7 days |
| Apparent Oral Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 7 days |
| Apparent Volume of Distribution (Vz/F) | plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 7 days |