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The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the pharmacokinetics (PK) of co-administered single dose simvastatin.
observational- quantify any effects of PF_04531083 on the PK of Simvastatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Experimental |
| |
| cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04531083 | Drug | PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of simvastatin. AUC, Cmax and half life. | days 1 and 14 of study | |
| Pharmacokinetics of simvastatin acid. AUC, Cmax and half life. | days 1 and 14 of study | |
| Trough concentrations of PF-04531083 2, 4, 7, 11 and 14 days post commencement of dosing | days 2, 4, 7, 11 and 14 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of PF-04531083 and simvastatin. Vital signs, laboratory tests and adverse events | days 1 and 15 of the study |
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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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| simvastatin | Drug | Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. |
|
| PF-04531083 | Drug | PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study. |
|
| simvastatin | Drug | Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study. |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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