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This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| first of three dosing cohorts | Other |
| |
| second of three dosing cohorts | Other |
| |
| third of three dosing cohorts | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04629991 | Drug | Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve | 2 weeks | |
| Safety/Tolerability e.g., reported adverse events and safety laboratory studies | 2 weeks | |
| Pharmacodynamics e.g., changes in a peripheral blood biomarker | 2 weeks |
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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 | 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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| PF-04629991 | Drug | Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses) |
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| PF-04629991 | Drug | Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991) |
|