Clinical Trial: Effect of Body Mass on Filgrastim Pharmacokinetics

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Effect of Body Mass on Filgrastim 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.


Detailed Summary:
Sponsor: Aaron Cumpston, PharmD, BCOP

Current Primary Outcome: Systemic clearance of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Alpha and beta half-life of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]
  • Maximum concentration (Cmax) of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]
  • Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]
  • Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients [ Time Frame: 24 hours ]


Original Secondary Outcome: Same as current

Information By: West Virginia University

Dates:
Date Received: October 29, 2012
Date Started: October 2012
Date Completion: December 2017
Last Updated: October 31, 2016
Last Verified: October 2016