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Effect of Body Mass on Filgrastim Pharmacokinetics
NCT01719432 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (1)
West Virginia
- West Virginia University Mary Babb Randolph Cancer Center — Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-12-05 |
| Est. Completion | 2020-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01719432
The ClinicalTrials.gov registry entry for NCT01719432 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aaron Cumpston, PharmD, BCOP, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Neutropenia appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01719432 reports 1 study location spanning 1 distinct geographic area — top geographies include West Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01719432 about?
NCT01719432 is a clinical study titled "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 st...
What is the current status of trial NCT01719432?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2012-12-05. Estimated completion is 2020-12.
What conditions does trial NCT01719432 study?
This clinical trial studies the following conditions: Neutropenia, Hematological Malignancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01719432?
This trial is sponsored by Aaron Cumpston, PharmD, BCOP, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01719432 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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