Hematological Malignancy, Neutropenia
Conditions
Keywords
Filgrastim, Obese, Non-obese, Pharmacokinetics
Brief summary
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.
Interventions
None listed
Sponsors
Aaron Cumpston, PharmD, BCOP
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic clearance of filgrastim in obese and non-obese patients | 24 hours |
Secondary
| Measure | 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 |
| 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 |
Countries
United States
Outcome results
None listed