Effect of Body Mass on Filgrastim Pharmacokinetics

Neutropenia Clinical Trial

Official title:

Effect of Body Mass on Filgrastim Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719432
• Other study ID #: WVU 021112
• Status: Completed
• Start date: December 5, 2012
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancy
• Neutropenia

Locations

Country	Name	City	State
United States	West Virginia University Mary Babb Randolph Cancer Center	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Aaron Cumpston, PharmD, BCOP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic clearance of filgrastim in obese and non-obese patients		24 hours
Secondary	Alpha and beta half-life of filgrastim in obese and non-obese patients		24 hours
Secondary	Maximum concentration (Cmax) of filgrastim in obese and non-obese patients		24 hours
Secondary	Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients		24 hours
Secondary	Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients		24 hours