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OpenTrials
Completed

NCT Number: NCT01719432

Effect of Body Mass on Filgrastim Pharmacokinetics

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.

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Key information

Conditions

Hematological Malignancy Agranulocytosis Body Weight Cytopenia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Site Neutropenia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia University Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Systemic clearance of filgrastim in obese and non-obese patients

    Time frame: 24 hours

Secondary outcomes

  1. Alpha and beta half-life of filgrastim in obese and non-obese patients

    Time frame: 24 hours

  2. Maximum concentration (Cmax) of filgrastim in obese and non-obese patients

    Time frame: 24 hours

  3. Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients

    Time frame: 24 hours

  4. Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Aaron Cumpston, PharmD, BCOP

Other

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2012
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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