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Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.
Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients | |||
| Non-obese patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Systemic clearance of filgrastim in obese and non-obese patients | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Alpha and beta half-life of filgrastim in obese and non-obese patients | 24 hours | |
| Maximum concentration (Cmax) of filgrastim in obese and non-obese patients | 24 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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Obese and non-obese patients receiving filgrastim
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Cumpston, PharmD, BCOP | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34767652 | Derived | Stewart AW, Shillingburg A, Petros W, Wen S, Piktel D, Moses R, Gibson LF, Craig M, Cumpston A. A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls. Pharmacotherapy. 2022 Jan;42(1):53-57. doi: 10.1002/phar.2646. Epub 2021 Nov 22. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009503 | Neutropenia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients |
| 24 hours |
| Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients | 24 hours |
| D000380 |
| Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |