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Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Dose: Cohort 1 | Experimental |
| |
| Multiple Dose: Cohort 2 | Experimental |
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| Multiple Dose: Cohort 3 | Experimental |
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| Multiple Dose: Cohort 4 | Experimental |
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| Relative Bioavilability: Cohort 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06305591 | Drug | 14 day repeated 20mg BID doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | 14 days |
| Maximum Observed Plasma Concentration (Cmax) | 14 days | |
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | 14 days |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption. | 14 days |
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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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| Placebo |
| Drug |
14 day repeated BID doses |
|
| PF-06305591 | Drug | 14 day repeated 80mg BID doses |
|
| Placebo | Drug | 14 day repeated BID doses |
|
| PF-06305591 | Drug | 14 day repeated 40mg BID doses |
|
| Placebo | Drug | 14 day repeated BID doses |
|
| PF-06305591 | Drug | 14 day repeated BID doses |
|
| PF-06305591 | Drug | relative bioavailability tablet vs. solution and food effect at 50mg dose |
|