Effect of Body Mass on Filgrastim Pharmacokinetics

Sponsor
Aaron Cumpston, PharmD, BCOP (Other)
Overall Status
Completed
CT.gov ID
NCT01719432
Collaborator
(none)
30
1
95.9
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effect of Body Mass on Filgrastim Pharmacokinetics
    Actual Study Start Date :
    Dec 5, 2012
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Obese patients

    Non-obese patients

    Outcome Measures

    Primary Outcome Measures

    1. Systemic clearance of filgrastim in obese and non-obese patients [24 hours]

    Secondary Outcome Measures

    1. Alpha and beta half-life of filgrastim in obese and non-obese patients [24 hours]

    2. Maximum concentration (Cmax) of filgrastim in obese and non-obese patients [24 hours]

    3. Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients [24 hours]

    4. Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West Virginia University Mary Babb Randolph Cancer Center Morgantown West Virginia United States 26506

    Sponsors and Collaborators

    • Aaron Cumpston, PharmD, BCOP

    Investigators

    • Principal Investigator: Aaron Cumpston, PharmD, BCOP, West Virginia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aaron Cumpston, PharmD, BCOP, Clinical Specialist - BMT, West Virginia University
    ClinicalTrials.gov Identifier:
    NCT01719432
    Other Study ID Numbers:
    • WVU 021112
    First Posted:
    Nov 1, 2012
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020
    Keywords provided by Aaron Cumpston, PharmD, BCOP, Clinical Specialist - BMT, West Virginia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 17, 2020