Effect of Body Mass on Filgrastim Pharmacokinetics
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/1/2018 |
| Start Date: | December 5, 2012 |
| End Date: | December 2018 |
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.
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.
Inclusion Criteria:
- Age greater than or equal to 18 years
- Receiving filgrastim at 5mcg/kg ± 10%
- Admitted as an inpatient with an expected stay of at least 24 hours
- Weight is > 190% of their ideal body weight (IBW) for "obese" patients or within 80 -
124% of IBW for matched control patients.
- Patient or their legally authorized representative understands and voluntarily signs
the written informed consent prior to any study-specific procedures. A copy of the
signed informed consent form will be retained by the treating institution.
Exclusion Criteria:
- Patients who have received filgrastim within 24 hours prior to enrollment
- Patients who have received pegfilgrastim within 14 days prior to enrollment
- Hypersensitivity reaction to filgrastim or any related product
- Patients who have taken lithium within 7 days of enrollment
- Serum Creatinine > 1.5 mg/dL
- Patients who are pregnant or breastfeeding
- Patients who are unable to understand and/or render informed consent
We found this trial at
1
site
Morgantown, West Virginia 26506
Principal Investigator: Aaron Cumpston, PharmD
Phone: 304-598-4511
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