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CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-945,598 with Grapefruit Juice | Experimental | CP-945,598 with Grapefruit Juice |
|
| CP-945,598 alone | Experimental | CP-945,598 alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-945,598 | Drug | Subjects take CP-945,598 alone for 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20. | 21 days | |
| Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22 | 21 days | |
| Adverse event monitoring throughout duration of the study | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21. | 2 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 | New Haven | Connecticut | 06511 | 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 |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| CP-945,598 |
| Drug |
Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21 |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |