Clinical trial NCT01719432: Effect of Body Mass on Filgrastim Pharmacokinetics
Official title: Effect of Body Mass on Filgrastim Pharmacokinetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancy
Neutropenia
Keywords: Filgrastim
Obese
Non-obese
Pharmacokinetics
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese and non-obese patients receiving filgrastim

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.


Eligibility criteria: 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

Primary outcomes:
measure: Systemic clearance of filgrastim in obese and non-obese patients
timeFrame: 24 hours
Secondary outcomes:
measure: Alpha and beta half-life of filgrastim in obese and non-obese patients
timeFrame: 24 hours
measure: Maximum concentration (Cmax) of filgrastim in obese and non-obese patients
timeFrame: 24 hours
measure: Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients
timeFrame: 24 hours
measure: Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients
timeFrame: 24 hours
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Aaron Cumpston, PharmD, BCOP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.