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This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-300 | Experimental |
| |
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-300, MEK inhibitor; oral | Drug | single dose, escalating |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. | Duration of study | |
| Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations. | Following a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. | Duration of study |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
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| Placebo |
| Drug |
matching placebo |
|